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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 K941095
Device Name MEDSAVER SYRINGE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact ANDREA J BILLARD
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact ANDREA J BILLARD
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/09/1994
Decision Date 06/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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