The following data is part of a premarket notification filed by Prosidyan, Inc with the FDA for Fibergraft Bg Morsels.
Device ID | K141956 |
510k Number | K141956 |
Device Name: | FIBERGRAFT 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-18 |
Decision Date | 2014-08-13 |
Summary: | summary |