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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 K962328
Device Name SINGLE USE INSTRUMENT TRAY
Applicant
MEDCARE MEDICAL GROUP, INC.
234 OLD HOMESTEAD HWY.
EAST SWANZEY,  NH  03446
Applicant Contact CRAIG J BELL
Correspondent
MEDCARE MEDICAL GROUP, INC.
234 OLD HOMESTEAD HWY.
EAST SWANZEY,  NH  03446
Correspondent Contact CRAIG J BELL
Regulation Number878.4800
Classification Product Code
FSM  
Date Received06/06/1996
Decision Date 08/09/1996
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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