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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, antistick
510(k) Number K122558
Device Name ULTRASAFE PASSIVE NEEDLE GUARD
Original Applicant
SAFETY SYRINGES, INC.
2875 loker ave e
carlsbad,  CA  92010
Original Contact suzanne richardson
Regulation Number880.5860
Classification Product Code
MEG  
Date Received08/22/2012
Decision Date 09/20/2012
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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