The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Mix Evac Ii.
| Device ID | K854077 |
| 510k Number | K854077 |
| Device Name: | MIX EVAC II |
| Classification | Mixer, Cement, For Clinical Use |
| Applicant | STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Contact | Harmon H Woodworth |
| Correspondent | Harmon H Woodworth STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Product Code | JDZ |
| CFR Regulation Number | 888.4210 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-07 |
| Decision Date | 1986-01-31 |