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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K955164
Device Name S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
Applicant
Habley Medical Technology Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY M MCNAMARA
Correspondent
Habley Medical Technology Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY M MCNAMARA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/13/1995
Decision Date 03/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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