Theg Korea, Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Theg Korea, Inc. · 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 is All Contact Lenses; product code is 86 - - - -- Ophthalmic; date published is 07/27/2010; address is 726-74 Hannam-Dong, Suit 1009, , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- 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
- 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) 86 - - - -- Ophthalmic Date Published: 07/27/2010 Desc: All Contact Lenses Notes: Class II; III
— 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) 86 - - - -- Ophthalmic Date Published: 07/27/2010 Desc: All Contact Lenses Notes: Class II ; III
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.