The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Uhmwpe Components-change In Packaging.
| Device ID | K940743 |
| 510k Number | K940743 |
| Device Name: | UHMWPE COMPONENTS-CHANGE IN PACKAGING |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KWY |
| Subsequent Product Code | HRY |
| Subsequent Product Code | JDB |
| Subsequent Product Code | KWI |
| Subsequent Product Code | LZN |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-16 |
| Decision Date | 1995-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295318088 | K940743 | 000 |
| 10603295318071 | K940743 | 000 |
| 10603295318064 | K940743 | 000 |