MONOMER EVACUATION SYSTEM
Device Facts
| Record ID | K780202 |
|---|---|
| Device Name | MONOMER EVACUATION SYSTEM |
| Applicant | Medishield, Inc. |
| Product Code | JDY · Orthopedic |
| Decision Date | Feb 21, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4220 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (§ 888.3027).
