The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Gas Plasma Sterilization.
| Device ID | K944538 |
| 510k Number | K944538 |
| Device Name: | GAS PLASMA STERILIZATION |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | JDB |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JWH |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1995-09-26 |