VYGON RED-O-PACK
Device Facts
| Record ID | K771015 |
|---|---|
| Device Name | VYGON RED-O-PACK |
| Applicant | Coastal Bend Medical Products, Inc. |
| Product Code | GCY · General, Plastic Surgery |
| Decision Date | Jul 11, 1977 |
| 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.
