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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 K042712
Device Name TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
Applicant
Safety Syringes, Inc.
1939 Palomar Oaks Way, Suite A
Carlsbad,  CA  92009
Applicant Contact THOMAS L HALL
Correspondent
Safety Syringes, Inc.
1939 Palomar Oaks Way, Suite A
Carlsbad,  CA  92009
Correspondent Contact THOMAS L HALL
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMF  
Date Received09/30/2004
Decision Date 10/15/2004
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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