Lensmam Co. Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Lensmam Co. Ltd, import alert is 89-08; country is KOREA (THE REPUBLIC OF); import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 07/31/2012; address is Rm. 304 & 305. Pos Techno. Sangdaewon 1- , dong, Jungwon-gu, Seongnam-si , Gyeonggi-do, Seongnam-si KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Lensmam Co. Ltd verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- Rm. 304 & 305. Pos Techno. Sangdaewon 1- , dong, Jungwon-gu, Seongnam-si , Gyeonggi-do, Seongnam-si KOREA (THE REPUBLIC OF) verified
- Date published
- 07/31/2012 verified
- Product code
- 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology each item verified
- FDA notes
- All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III | All device products; Class I/II/III each item verified
What the source says
Lensmam Co. Ltd Date Published : 07/31/2012 Rm. 304 & 305. Pos Techno. Sangdaewon 1- , dong, Jungwon-gu, Seongnam-si , Gyeonggi-do, Seongnam-si KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
73 - - - -- Anesthesiology Date Published: 07/31/2012 Notes: All device products; Class I/II/III 74 - - - -- Cardiovascular Date Published: 07/31/2012 Notes: All device products; Class I/II/III 76 - - - -- Dental Date Published: 07/31/2012 Notes: All device products; Class I/II/III 77 - - - -- Ear,Nose And Throat Date Published: 07/31/2012 Notes: All device products; Class I/II/III 78 - - - -- Gastroenterological & Urological Date Published: 07/31/2012 Notes: All device products; Class I/II/III 79 - - - -- General & Plastic Surgery Date Published: 07/31/2012 Notes: All device products; Class I/II/III 80 - - - -- General Hospital/Personal Use Date Published: 07/31/2012 Notes: All device products; Class I/II/III 84 - - - -- Neurological Date Published: 07/31/2012 Notes: All device products; Class I/II/III 85 - - - -- Obstetrical & Gynecological Date Published: 07/31/2012 Notes: All device products; Class I/II/III 86 - - - -- Ophthalmic Date Published: 07/31/2012 Notes: All device products; Class I/II/III 87 - - - -- Orthopedic Date Published: 07/31/2012 Notes: All device products; Class I/II/III 89 - - - -- Physical Medicine Date Published: 07/31/2012 Notes: All device products; Class I/II/III 90 - - - -- Radiology Date Published: 07/31/2012 Notes: All device products; Class I/II/III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html