K991968 is an FDA 510(k) clearance for the CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).
Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on July 30, 1999, 49 days after receiving the submission on June 11, 1999.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K991968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1999 |
| Decision Date | July 30, 1999 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MDA — Elastomer, Silicone, For Scar Management |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4025 |