PS-ROUND SURG. DRAIN & CONNECTOR
Device Facts
| Record ID | K813377 |
|---|---|
| Device Name | PS-ROUND SURG. DRAIN & CONNECTOR |
| Applicant | Pudenz-Schulte Medical Research Corp. |
| Product Code | GCY · General, Plastic Surgery |
| Decision Date | Jan 5, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4680 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.