Cleared Traditional

TOURNIQUET

K881398 · Barretta Products, Research and Development, Inc. · General & Plastic Surgery

Apr 1988

Decision

25d

Days

Class 1

Risk

About This 510(k) Submission

K881398 is an FDA 510(k) clearance for the TOURNIQUET, a Tourniquet, Nonpneumatic (Class I — General Controls, product code GAX), submitted by Barretta Products, Research and Development, Inc. (Mobile, US). The FDA issued a Cleared decision on April 29, 1988, 25 days after receiving the submission on April 4, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5900.

Submission Details

510(k) Number	K881398 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 1988
Decision Date	April 29, 1988
Days to Decision	25 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—