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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 K980987
Device Name BECTON DICKINSON SYRINGE
Original Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 becton dr.
franklin lakes,  NJ  07417 -1880
Original Contact gregory morgan
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/17/1998
Decision Date 06/11/1998
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
Recalls CDRH Recalls
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