Cleared Traditional

DEGANIA SILICONE TOURNIQUET

K875092 · Degania Silicone , Ltd. · General & Plastic Surgery
Jan 1988
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K875092 is an FDA 510(k) clearance for the DEGANIA SILICONE TOURNIQUET, a Tourniquet, Nonpneumatic (Class I — General Controls, product code GAX), submitted by Degania Silicone , Ltd. (Emek Hayarden, IL). The FDA issued a Cleared decision on January 7, 1988, 28 days after receiving the submission on December 10, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5900.

Submission Details

510(k) Number K875092 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1987
Decision Date January 07, 1988
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