K961194 is an FDA 510(k) clearance for the ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN. This device is classified as a Catheter, Peritoneal (Class I - General Controls, product code GBW).
Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on August 8, 1996, 134 days after receiving the submission on March 27, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K961194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1996 |
| Decision Date | August 08, 1996 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBW — Catheter, Peritoneal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |