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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 K151870
Device Name BD U-500 INSULIN SYRINGE
Applicant
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07666
Applicant Contact LUISA F. METRIO
Correspondent
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07666
Correspondent Contact Matthew F. Trachtenberg
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/09/2015
Decision Date 07/08/2016
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
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