The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Techmedica Mueller Type Polyethylene Acetbul Cup.
| Device ID | K925181 |
| 510k Number | K925181 |
| Device Name: | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| 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 | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-14 |
| Decision Date | 1993-02-05 |