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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 DRIVE MC237
franklin lakes,  NJ  07417
Applicant Contact john roberts
Correspondent
Becton, Dickinson and Company
1 BECTON DRIVE MC237
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
Recalls CDRH Recalls
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