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 |