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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 K170386
Device Name BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
Applicant
Becton Dickinson & Company
1 Becton Dr.
Franklin Lakes,  NJ  07666
Applicant Contact Riddhish Patel
Correspondent
Becton Dickinson & Company
1 Becton Dr.
Franklin Lakes,  NJ  07666
Correspondent Contact Riddhish Patel
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/08/2017
Decision Date 04/12/2017
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
Predetermined Change
Control Plan Authorized		 No
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