K963839 is an FDA 510(k) clearance for the CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500, a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I — General Controls, product code GCY), submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on December 12, 1996, 79 days after receiving the submission on September 24, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K963839 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 1996 |
| Decision Date | December 12, 1996 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4680 |