Cleared Traditional

UNIVERSAL TOURNIQUET

K873928 · Dryden Corp. · General & Plastic Surgery
Oct 1987
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K873928 is an FDA 510(k) clearance for the UNIVERSAL TOURNIQUET, a Tourniquet, Nonpneumatic (Class I — General Controls, product code GAX), submitted by Dryden Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 23, 1987, 28 days after receiving the submission on September 25, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5900.

Submission Details

510(k) Number K873928 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1987
Decision Date October 23, 1987
Days to Decision 28 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