K953953 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF. This device is classified as a Tourniquet, Pneumatic (Class I - General Controls, product code KCY).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on September 29, 1995, 38 days after receiving the submission on August 22, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K953953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1995 |
| Decision Date | September 29, 1995 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KCY — Tourniquet, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.5910 |