# Theg Korea, Inc. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 726-74 Hannam-Dong, Suit 1009, , Seoul, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 07/27/2010 _(verified: appears in the quote below)_
- **Product code:** 86 - - - -- Ophthalmic _(verified: appears in the quote below)_
- **Product:** All Contact Lenses _(verified: appears in the quote below)_
- **FDA notes:** Class II; III _(verified: appears in the quote below)_

## 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

## 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

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).