Cleared Traditional

SINGLE USE INSTRUMENT TRAY

K962328 · Medcare Medical Group, Inc. · General & Plastic Surgery

Aug 1996

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K962328 is an FDA 510(k) clearance for the SINGLE USE INSTRUMENT TRAY, a Tray, Surgical, Instrument (Class I — General Controls, product code FSM), submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on August 9, 1996, 64 days after receiving the submission on June 6, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K962328 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 1996
Decision Date	August 09, 1996
Days to Decision	64 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement