The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for All Polyethylene Cemented Acetabular Cup.
| Device ID | K943696 |
| 510k Number | K943696 |
| Device Name: | ALL POLYETHYLENE CEMENTED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-29 |
| Decision Date | 1995-05-17 |