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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 K182589
Device Name BD Plastipak Syringe
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Leslie Robinson-Frye
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/20/2018
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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