BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
Device Facts
| Record ID | K933319 |
|---|---|
| Device Name | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM |
| Applicant | Birtcher Medical Systems, Inc. |
| Product Code | GCY · General, Plastic Surgery |
| Decision Date | Oct 27, 1993 |
| 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.