The following data is part of a premarket notification filed by Prosidyan, Inc with the FDA for Bg Morsels.
| Device ID | K132805 |
| 510k Number | K132805 |
| Device Name: | BG MORSELS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PROSIDYAN, INC 1835 MARKET STREET, 29TH FLOOR Philadelpiha, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan PROSIDYAN, INC 1835 MARKET STREET, 29TH FLOOR Philadelpiha, 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 | 2013-09-06 |
| Decision Date | 2014-03-14 |
| Summary: | summary |