K915867 is an FDA 510(k) clearance for the SOLCOVAC WOUND DRAINAGE SYSTEM. This device is classified as a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I - General Controls, product code GCY).
Submitted by Solco Basle, Inc. (Hingham, US). The FDA issued a Cleared decision on August 14, 1992, 227 days after receiving the submission on December 31, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K915867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 31, 1991 |
| Decision Date | August 14, 1992 |
| Days to Decision | 227 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 |