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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 K022130
Device Name BD VACUTAINER PLUS PST II TUBE
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
MC 300
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact JING ZHANG
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
MC 300
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact JING ZHANG
Regulation Number862.1675
Classification Product Code
JKA  
Date Received07/01/2002
Decision Date 07/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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