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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 K151766
Device Name BD Single Use, Hypodermic Syringe
Applicant
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07417
Applicant Contact MURTAZA RANA
Correspondent
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07417
Correspondent Contact MURTAZA RANA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/30/2015
Decision Date 09/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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