The following data is part of a premarket notification filed by Bioscience, Inc. with the FDA for Biofix Biodegradable Self-reinforced Poly-l-lactide (sr-plla) Mini-tack.
| Device ID | K955003 |
| 510k Number | K955003 |
| Device Name: | BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIOSCIENCE, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BIOSCIENCE, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-01 |
| Decision Date | 1996-01-31 |