Cleared Traditional

TOURNIQUET

K851482 · Polymer Technology Corp. · General & Plastic Surgery
Apr 1985
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K851482 is an FDA 510(k) clearance for the TOURNIQUET, a Tourniquet, Nonpneumatic (Class I — General Controls, product code GAX), submitted by Polymer Technology Corp. (Whitwater, US). The FDA issued a Cleared decision on April 29, 1985, 14 days after receiving the submission on April 15, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5900.

Submission Details

510(k) Number K851482 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1985
Decision Date April 29, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GAX — Tourniquet, Nonpneumatic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.5900