DongBang Medical Co. Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For DongBang Medical 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 Derma-Q For Microneedle | Dermapen Needle | Derma-Q For Microneedle; product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - AB Needle, Suturing, Disposable | 79 M - - DM Instrument, Manual, General Surgical; date published is 10/22/2015; address is Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- DongBang Medical 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
- Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF) verified
- Date published
- 10/22/2015 verified
- Product code
- 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - AB Needle, Suturing, Disposable | 79 M - - DM Instrument, Manual, General Surgical each item verified
- Product
- Derma-Q For Microneedle | Dermapen Needle | Derma-Q For Microneedle each item verified
- FDA notes
- The device has no 510(k) clearance or PMA approval verified
What the source says
DongBang Medical Co. Ltd. Date Published : 10/22/2015 Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam 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
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 04/21/2016 Desc: Derma-Q For Microneedle 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 79 M - - DM Instrument, Manual, General Surgical Date Published: 04/21/2016 Desc: Derma-Q For Microneedle Notes:
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html