Dongbang Acupuncture Inc · 89-08 · KOREA (THE REPUBLIC OF)
For Dongbang Acupuncture 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 Dermapen Needle; product code is 79 G - - AB Needle, Suturing, Disposable; date published is 10/22/2015; address is Woorim W-City 313 Sam Pyung Dong , Seongnam-Si, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Dongbang Acupuncture 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
- Woorim W-City 313 Sam Pyung Dong , Seongnam-Si, KOREA (THE REPUBLIC OF) verified
- Date published
- 10/22/2015 verified
- Product code
- 79 G - - AB Needle, Suturing, Disposable verified
- Product
- Dermapen Needle verified
- FDA notes
- The device has no 510(k) clearance or PMA approval verified
What the source says
Dongbang Acupuncture Inc Date Published : 10/22/2015 Woorim W-City 313 Sam Pyung Dong , Seongnam-Si, KOREA (THE REPUBLIC OF) 79 G - - AB Needle, Suturing, Disposable Date Published: 10/22/2015 Desc: Dermapen Needle Notes: The device has no 510(k) clearance or PMA approval
— 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.