K981902 is an FDA 510(k) clearance for the SPENCO SILICONE GEL SHEET. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).
Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on June 25, 1998, 24 days after receiving the submission on June 1, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K981902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1998 |
| Decision Date | June 25, 1998 |
| Days to Decision | 24 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 |