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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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