K935803 is an FDA 510(k) clearance for the CICA-CARE SILICONE GEL SHEET. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).
Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on February 3, 1994, 63 days after receiving the submission on December 2, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K935803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1993 |
| Decision Date | February 03, 1994 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MDA — Elastomer, Silicone, For Scar Management |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4025 |