The following data is part of a premarket notification filed by Biogeneration with the FDA for Profusion Bone Void Filler.
| Device ID | K973704 |
| 510k Number | K973704 |
| Device Name: | PROFUSION BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOGENERATION 9160 HIGHWAY 64 SUITE 12 Arlington, TN 38002 |
| Contact | Bernard F Grisoni |
| Correspondent | Bernard F Grisoni BIOGENERATION 9160 HIGHWAY 64 SUITE 12 Arlington, TN 38002 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-29 |
| Decision Date | 1998-04-03 |
| Summary: | summary |