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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
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Applicant Contact KIMBERLY LANE
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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