The following data is part of a premarket notification filed by Biogeneration with the FDA for Profusion Bone Void Filler Kit.
| Device ID | K031838 |
| 510k Number | K031838 |
| Device Name: | PROFUSION BONE VOID FILLER KIT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOGENERATION 9160 HIGHWAY 64 SUITE 12 Lakeland, TN 38002 |
| Contact | Bernard F Grisoni |
| Correspondent | Bernard F Grisoni BIOGENERATION 9160 HIGHWAY 64 SUITE 12 Lakeland, 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 | 2003-06-16 |
| Decision Date | 2003-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862835000415 | K031838 | 000 |
| 00862835000408 | K031838 | 000 |
| 00862835000422 | K031838 | 000 |
| 00862835000453 | K031838 | 000 |
| 00862835000446 | K031838 | 000 |
| 00862835000439 | K031838 | 000 |
| 00862835000477 | K031838 | 000 |