The following data is part of a premarket notification filed by Bioscience, Inc. with the FDA for Biofix Absorbable Self-reinforced Poly-l-lactide.
| Device ID | K925098 |
| 510k Number | K925098 |
| Device Name: | BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-08 |
| Decision Date | 1994-07-19 |