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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 K854746
Device Name SURGICAL INSTRUMENT TRAY
Applicant
Zbi, Inc.
1138 W. Chester Pike, Suite
7
West Chester,  PA  19382
Applicant Contact MATTHEW H BROWN
Correspondent
Zbi, Inc.
1138 W. Chester Pike, Suite
7
West Chester,  PA  19382
Correspondent Contact MATTHEW H BROWN
Regulation Number878.4800
Classification Product Code
FSM  
Date Received11/26/1985
Decision Date 12/17/1985
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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