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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 K030573
Device Name BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
Applicant
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
1 BECTON DR., BECTON BLDG.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact M. WENDY BALLESTEROS
Correspondent
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
1 BECTON DR., BECTON BLDG.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact M. WENDY BALLESTEROS
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received02/24/2003
Decision Date 05/08/2003
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
Recalls CDRH Recalls
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