Vassen Co. Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Vassen Co. Ltd., 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 Contact Lens; product code is 86 M - - VN Lens, Contact (Disposable); date published is 11/18/2011; address is (Ju)Inteohogeun , 50 Seotan-Ro; Jinwi-Myeon , Pyeongtaek, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Vassen 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
- (Ju)Inteohogeun , 50 Seotan-Ro; Jinwi-Myeon , Pyeongtaek, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 11/18/2011 verified
- Product code
- 86 M - - VN Lens, Contact (Disposable) verified
- Product
- Contact Lens verified
- FDA notes
- class II/III verified
What the source says
Vassen Co. Ltd. Date Published : 11/18/2011 (Ju)Inteohogeun , 50 Seotan-Ro; Jinwi-Myeon , Pyeongtaek, Gyeonggi 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 M - - VN Lens, Contact (Disposable) Date Published: 11/18/2011 Desc: Contact Lens Notes: class II/III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html