Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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