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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 K121283
Device Name BD EMERALD SAF-T SINGLE USE, HYPODERMIC
Original Applicant
Becton, Dickinson and Company
1 becton drive mc237
franklin lakes,  NJ  07417
Original Contact kimberly lane
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/30/2012
Decision Date 05/30/2012
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
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