Cleared Traditional

INSTRUMENT TRAY LINER

K971217 · General Hospital Supply Corp. · General & Plastic Surgery

May 1997

Decision

34d

Days

Class 1

Risk

About This 510(k) Submission

K971217 is an FDA 510(k) clearance for the INSTRUMENT TRAY LINER, a Tray, Surgical, Instrument (Class I — General Controls, product code FSM), submitted by General Hospital Supply Corp. (Wilton, US). The FDA issued a Cleared decision on May 6, 1997, 34 days after receiving the submission on April 2, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K971217 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 1997
Decision Date	May 06, 1997
Days to Decision	34 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement