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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 K013971
FOIA Releasable 510(k) K013971
Device Name BD VACUTAINER SAFETY COAGULATION TUBE
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact KEITH SMITH
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact KEITH SMITH
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/03/2001
Decision Date 02/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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