Theg Korea, Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Theg Korea, Inc., 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 is All Contact Lenses; product code is 86 - - - -- Ophthalmic; date published is 07/27/2010; address is listed twice: 726-74 Hannam-Dong, Suit 1009, , Seoul, KOREA (THE REPUBLIC OF) and Suite 1508 Taechidong 889 5 , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Theg Korea, Inc. 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
- 726-74 Hannam-Dong, Suit 1009, , Seoul, KOREA (THE REPUBLIC OF) verified
- Suite 1508 Taechidong 889 5 , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) also listed
- Date published
- 07/27/2010 verified
- Product code
- 86 - - - -- Ophthalmic verified
- Product
- All Contact Lenses verified
- FDA notes
- Class II; III verified
What the source says
Theg Korea, Inc. Date Published : 07/27/2010 726-74 Hannam-Dong, Suit 1009, , Seoul, 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, Product and FDA notes
86 - - - -- Ophthalmic Date Published: 07/27/2010 Desc: All Contact Lenses Notes: Class II; III
— all from accessdata.fda.gov, retrieved 2026-09-15
The same source also states
Theg Korea, Inc. Date Published : 07/27/2010 Suite 1508 Taechidong 889 5 , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Product code
86 - - - -- Ophthalmic Date Published: 07/27/2010 Desc: All Contact Lenses Notes: Class II ; III
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html