Cleared Traditional

KINDERWRAP

K872003 · The Kinder Co. · General & Plastic Surgery
Jun 1987
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K872003 is an FDA 510(k) clearance for the KINDERWRAP, a Tourniquet, Nonpneumatic (Class I — General Controls, product code GAX), submitted by The Kinder Co. (Ypsilanti, US). The FDA issued a Cleared decision on June 23, 1987, 28 days after receiving the submission on May 26, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5900.

Submission Details

510(k) Number K872003 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 1987
Decision Date June 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