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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 K953463
Device Name VACUTAINER PLUS TUBES
Applicant
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact DENISE DECHENE
Correspondent
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact DENISE DECHENE
Regulation Number862.1675
Classification Product Code
JKA  
Date Received07/24/1995
Decision Date 09/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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