Neobiotech Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Neobiotech Co., Ltd. · 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 "RegenOss" Freeze Dried Bone Allograft; product code is 76 L - - YC Bone Grafting Material, Synthetic; date published is 08/09/2018; address is #1001, 36, DIGITAL-RO 27 GIL , 103, e-space, 212-26, Guro-dong , Guro-gu, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Neobiotech 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
- #1001, 36, DIGITAL-RO 27 GIL , 103, e-space, 212-26, Guro-dong , Guro-gu, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) verified
- Date published
- 08/09/2018 verified
- Product code
- 76 L - - YC Bone Grafting Material, Synthetic verified
- Product
- "RegenOss" Freeze Dried Bone Allograft verified
- FDA notes
- Class III; 9/25/2009 verified
What the source says
Neobiotech Co., Ltd. Date Published : 08/09/2018 #1001, 36, DIGITAL-RO 27 GIL , 103, e-space, 212-26, Guro-dong , Guro-gu, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) 76 L - - YC Bone Grafting Material, Synthetic Date Published: 08/09/2018 Desc: "RegenOss" Freeze Dried Bone Allograft Notes: Class III; 9/25/2009
— 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.