K926290 is an FDA 510(k) clearance for the BURN SHEET. This device is classified as a Sheet, Burn (Class I - General Controls, product code FPY).
Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on April 20, 1993, 127 days after receiving the submission on December 14, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5180.
| 510(k) Number | K926290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1992 |
| Decision Date | April 20, 1993 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FPY — Sheet, Burn |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5180 |