ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN
Device Facts
| Record ID | K920819 |
|---|---|
| Device Name | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN |
| Applicant | Astra Meditec AB |
| Product Code | GCY · General, Plastic Surgery |
| Decision Date | Mar 24, 1993 |
| Decision | SESK |
| 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.
