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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K003627
Device Name EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
Applicant
Exelint International, Co.
5840 W. Centinela Ave.
Los Angeles,  CA  90231
Applicant Contact ARMAND HAMID
Correspondent
Exelint International, Co.
5840 W. Centinela Ave.
Los Angeles,  CA  90231
Correspondent Contact ARMAND HAMID
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FIE  
Date Received11/24/2000
Decision Date 02/08/2001
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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