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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 K944025
Device Name SURGICAL INSTRUMENT TRAY
Applicant
Riley Medical, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DIANE E MINEAR
Correspondent
Riley Medical, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DIANE E MINEAR
Regulation Number878.4800
Classification Product Code
FSM  
Date Received08/17/1994
Decision Date 11/22/1994
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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