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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 K944425
Device Name ULTRASAFE ASPIRATING SYRINGE
Applicant
Safety Syringes, Inc.
250 W. Colorado Blvd.
Suite 101
Arcadia,  CA  91007
Applicant Contact J. R FIRTH
Correspondent
Safety Syringes, Inc.
250 W. Colorado Blvd.
Suite 101
Arcadia,  CA  91007
Correspondent Contact J. R FIRTH
Regulation Number880.5860
Classification Product Code
MEG  
Date Received09/12/1994
Decision Date 01/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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