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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 K023331
Device Name BD VACUTAINER SST II PLUS TUBES
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 Received10/04/2002
Decision Date 11/25/2002
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
Predetermined Change
Control Plan Authorized		 No
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