SIMPLEX ENHANCEMENT MIXER
Device Facts
| Record ID | K853310 |
|---|---|
| Device Name | SIMPLEX ENHANCEMENT MIXER |
| Applicant | Howmedica Corp. |
| Product Code | JDZ · Orthopedic |
| Decision Date | Sep 11, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4210 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (§ 888.3027).
