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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 K843723
Device Name STERILE INSTRUMENT TRAYS-VARIOUS
Applicant
E.M. ADAMS
121 WEST ST.
MEDFIELD,  MA  02052
Applicant Contact RICHARD K DONAHUE
Correspondent
E.M. ADAMS
121 WEST ST.
MEDFIELD,  MA  02052
Correspondent Contact RICHARD K DONAHUE
Regulation Number878.4800
Classification Product Code
FSM  
Date Received09/24/1984
Decision Date 10/23/1984
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
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