Lensmam Co. Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Lensmam Co. Ltd · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; 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)"; country is KOREA (THE REPUBLIC OF); 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 2026-09-16.
- 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) 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html