K912472 is an FDA 510(k) clearance for the DEROYAL WOUND DRESSING. This device is classified as a Closure, Wound, Adhesive (Class I - General Controls, product code MGO).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 2, 1991, 120 days after receiving the submission on June 4, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4018.
| 510(k) Number | K912472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1991 |
| Decision Date | October 02, 1991 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MGO — Closure, Wound, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4018 |