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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, hypodermic, single lumen
510(k) Number K121908
Device Name SAFETY INFUSION SET
Original Applicant
GREINER BIO-ONE NORTH AMERICA, INC.
p.o. box 103
baldwin,  MD  21013
Original Contact judith smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/29/2012
Decision Date 07/25/2012
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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