The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Muller Straight Stem Femoral Prosthesis.
| Device ID | K923808 |
| 510k Number | K923808 |
| Device Name: | MULLER STRAIGHT STEM FEMORAL PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Contact | Dave Samson |
| Correspondent | Dave Samson TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-29 |
| Decision Date | 1993-07-27 |