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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 K972878
Device Name ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
Applicant
Safety Syringes, Inc.
250 W. Colorado Blvd.
Suite 101
Arcadia,  CA  91007
Applicant Contact ANTHONY PEREZ
Correspondent
Safety Syringes, Inc.
250 W. Colorado Blvd.
Suite 101
Arcadia,  CA  91007
Correspondent Contact ANTHONY PEREZ
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/04/1997
Decision Date 10/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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