P.F.C. CEMENT PRESSURIZING SYSTEM
Device Facts
| Record ID | K943906 |
|---|---|
| Device Name | P.F.C. CEMENT PRESSURIZING SYSTEM |
| Applicant | Johnson & Johnson Professionals, Inc. |
| Product Code | KIH · Orthopedic |
| Decision Date | Dec 21, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.
