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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K110771
Device Name BD SINGLE USE, HYPODERMIC SYRINGE
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Applicant Contact JOHN ROBERTS
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Correspondent Contact JOHN ROBERTS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/21/2011
Decision Date 05/13/2011
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
Recalls CDRH Recalls
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