Neobiotech Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Neobiotech 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 "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 2026-09-30.
- 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)
— 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
76 L - - YC Bone Grafting Material, Synthetic Date Published: 08/09/2018 Desc: "RegenOss" Freeze Dried Bone Allograft Notes: Class III; 9/25/2009
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html