The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for P.m. Hip-femoral Prosthesis.
| Device ID | K853916 |
| 510k Number | K853916 |
| Device Name: | P.M. HIP-FEMORAL PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville, CA 94506 -4617 |
| Contact | Barry M Calvarese |
| Correspondent | Barry M Calvarese ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville, CA 94506 -4617 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-23 |
| Decision Date | 1985-12-27 |