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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 K024109
Device Name BD ULTRA-FINE III PEN NEEDLE
Applicant
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Applicant Contact JOHN A SCHALGO
Correspondent
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Correspondent Contact JOHN A SCHALGO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/13/2002
Decision Date 12/30/2002
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
Predetermined Change
Control Plan Authorized		 No
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