The following data is part of a premarket notification filed by Biogennix, Llc with the FDA for Biogennix Rpc.
| Device ID | K093342 |
| 510k Number | K093342 |
| Device Name: | BIOGENNIX RPC |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOGENNIX, LLC 19200 VON KARMAN AVE SUITE 400 Irvine, CA 92612 |
| Contact | Edwin C Shors |
| Correspondent | Edwin C Shors BIOGENNIX, LLC 19200 VON KARMAN AVE SUITE 400 Irvine, CA 92612 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2010-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812593020620 | K093342 | 000 |
| 00812593020613 | K093342 | 000 |
| 00812593020606 | K093342 | 000 |
| 00812593021580 | K093342 | 000 |