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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 K954592
Device Name VACUTAINER BRAND PST PLASMA SEPARATION TUBE
Applicant
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact DENISE DUCHENE
Correspondent
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact DENISE DUCHENE
Regulation Number862.1675
Classification Product Code
JKA  
Date Received10/02/1995
Decision Date 11/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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