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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 K031200
Device Name MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact CYNTHIA LACATENA
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact CYNTHIA LACATENA
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/16/2003
Decision Date 06/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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