K871982 is an FDA 510(k) clearance for the TOURNIQUET PRESSURE REGULATOR. This device is classified as a Tourniquet, Pneumatic (Class I - General Controls, product code KCY).
Submitted by Avec Scientific Design Corp. (Philadelphia, US). The FDA issued a Cleared decision on June 9, 1987, 18 days after receiving the submission on May 22, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K871982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1987 |
| Decision Date | June 09, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KCY — Tourniquet, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.5910 |