Dongbang Acupuncture Inc · 89-08 · KOREA (THE REPUBLIC OF)
For Dongbang Acupuncture 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 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 2026-09-30.
- 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)
— 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 - - AB Needle, Suturing, Disposable Date Published: 10/22/2015 Desc: Dermapen Needle Notes: The device has no 510(k) clearance or PMA approval
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html