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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 K051899
Device Name BD PEN NEEDLE
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
MC 300
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact JOHN SCHALAGO
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
MC 300
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact JOHN SCHALAGO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/13/2005
Decision Date 09/13/2005
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
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