K014036 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).
Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on February 14, 2002, 69 days after receiving the submission on December 7, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K014036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2001 |
| Decision Date | February 14, 2002 |
| Days to Decision | 69 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 |