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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K971217
Device Name INSTRUMENT TRAY LINER
Applicant
General Hospital Supply Corp.
196 Danbury Rd.
Wilton,  CT  06897
Applicant Contact PHILLIP DAVIS
Correspondent
General Hospital Supply Corp.
196 Danbury Rd.
Wilton,  CT  06897
Correspondent Contact PHILLIP DAVIS
Regulation Number878.4800
Classification Product Code
FSM  
Date Received04/02/1997
Decision Date 05/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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