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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
Applicant
Safety Syringes, Inc.
2875 Loker Ave. E
Carlsbad,  CA  92010
Applicant Contact SUZANNE RICHARDSON
Correspondent
Safety Syringes, Inc.
2875 Loker Ave. E
Carlsbad,  CA  92010
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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