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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 K912053
Device Name OPEN HEART TRAY
Applicant
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P.SCHWARTZ
Correspondent
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P.SCHWARTZ
Regulation Number878.4800
Classification Product Code
FSM  
Date Received05/09/1991
Decision Date 08/26/1991
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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