K930615 is an FDA 510(k) clearance for the AUTOVAC CLOSED WOUND SUCTION SYSTEM. This device is classified as a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I - General Controls, product code GCY).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on February 22, 1994, 382 days after receiving the submission on February 5, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K930615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1993 |
| Decision Date | February 22, 1994 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4680 |