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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 K023752
Device Name BD INTEGRA SYRINGE
Original Applicant
BD
one becton drive mc226
franklin lakes,  NJ  07417
Original Contact pasquale amato
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MEG  
Date Received11/08/2002
Decision Date 02/07/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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