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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K011984
Device Name BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact M. WENDY BOSSHARDT
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact M. WENDY BOSSHARDT
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
JKA  
Date Received06/26/2001
Decision Date 08/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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