SUNWOO I&T · 89-08 · KOREA (THE REPUBLIC OF)
For SUNWOO I&T · 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 Dermapen; product code is 79 G - - FE Brush, Dermabrasion; date published is 09/09/2013; address is 1f, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- SUNWOO I&T 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
- 1f, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF) verified
- Date published
- 09/09/2013 verified
- Product code
- 79 G - - FE Brush, Dermabrasion verified
- Product
- Dermapen verified
- FDA notes
- class II verified
What the source says
SUNWOO I&T Date Published : 09/09/2013 1f, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF) 79 G - - FE Brush, Dermabrasion Date Published: 09/09/2013 Desc: Dermapen Notes: class II
— 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.