K013732 is an FDA 510(k) clearance for the GELZONE. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).
Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on February 7, 2002, 90 days after receiving the submission on November 9, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K013732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2001 |
| Decision Date | February 07, 2002 |
| Days to Decision | 90 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 |