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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 K242320
Device Name BD Vacutainer® One Use Holder
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact Sravan Rajamani
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact Sravan Rajamani
Regulation Number862.1675
Classification Product Code
JKA  
Date Received08/05/2024
Decision Date 11/01/2024
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
Predetermined Change
Control Plan Authorized		 No
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