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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 K110703
Device Name BD AUTOSHIELD DUO PEN NEEDLE
Applicant
Becton, Dickinson and Company
1 BECTON DRIVE MC 372
FRANKLIN LAKES,  NJ  07417
Applicant Contact CYNTHIA LACATENA
Correspondent
Becton, Dickinson and Company
1 BECTON DRIVE MC 372
FRANKLIN LAKES,  NJ  07417
Correspondent Contact CYNTHIA LACATENA
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/14/2011
Decision Date 07/27/2011
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
Predetermined Change
Control Plan Authorized		 No
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