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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K220212
Device Name BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Kelly Hilliger
Correspondent
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Kelly Hilliger
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received01/26/2022
Decision Date 03/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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