The following data is part of a premarket notification filed by Prosidyan Inc. with the FDA for Fibergraft Bg Morsels.
| Device ID | K151154 |
| 510k Number | K151154 |
| Device Name: | FIBERGRAFT BG Morsels |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PROSIDYAN INC. 30 TECHNOLOGY DRIVE Warren, NJ 07059 |
| Contact | Charanpreet S Bagga |
| Correspondent | Janice M Hogan HOGAN LOVELLS US LLP 1835 MARKET ST 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-30 |
| Decision Date | 2015-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856879006137 | K151154 | 000 |
| 00856879006076 | K151154 | 000 |
| 00856879006069 | K151154 | 000 |
| 00856879006052 | K151154 | 000 |
| 00856879006007 | K151154 | 000 |
| 00856879006724 | K151154 | 000 |
| 00856879006717 | K151154 | 000 |
| 00856879006700 | K151154 | 000 |