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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 K190054
Device Name BD Insulin Syringe
Applicant
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Meriam Youssef
Correspondent
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Meriam Youssef
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/11/2019
Decision Date 10/21/2019
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
Recalls CDRH Recalls
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