The following data is part of a premarket notification filed by Kensey Nash Corporation with the FDA for Kensey Nash Bone Void Filler.
| Device ID | K060917 |
| 510k Number | K060917 |
| Device Name: | KENSEY NASH BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Jennifer J Bosley |
| Correspondent | Jennifer J Bosley KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-04 |
| Decision Date | 2006-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812337021562 | K060917 | 000 |
| 00812337021555 | K060917 | 000 |
| 00812337021548 | K060917 | 000 |
| 00812337021531 | K060917 | 000 |
| 00812337021524 | K060917 | 000 |
| 00812337021517 | K060917 | 000 |