SUNWOO I&T · 89-08 · KOREA (THE REPUBLIC OF)
For SUNWOO I&T, 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 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 2026-09-30.
- 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)
— 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
79 G - - FE Brush, Dermabrasion Date Published: 09/09/2013 Desc: Dermapen Notes: class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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