K930759 is an FDA 510(k) clearance for the CP & S STERILE BURN SHEET. This device is classified as a Sheet, Burn (Class I - General Controls, product code FPY).
Submitted by Consolidated Products & Services, Inc. (North Quincy, US). The FDA issued a Cleared decision on January 21, 1994, 343 days after receiving the submission on February 12, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5180.
| 510(k) Number | K930759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1993 |
| Decision Date | January 21, 1994 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FPY — Sheet, Burn |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5180 |