The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Prism Bone Cement Mixing System.
| Device ID | K925025 |
| 510k Number | K925025 |
| Device Name: | PRISM BONE CEMENT MIXING SYSTEM |
| Classification | Mixer, Cement, For Clinical Use |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Robert F Sullivan |
| Correspondent | Robert F Sullivan DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDZ |
| CFR Regulation Number | 888.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-02 |
| Decision Date | 1994-01-05 |