K813394 is an FDA 510(k) clearance for the DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Cox-Uphuff Intl. (Walker, US). The FDA issued a Cleared decision on January 22, 1982, 49 days after receiving the submission on December 4, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K813394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1981 |
| Decision Date | January 22, 1982 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |