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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 K152183
Device Name EXELINT SecureTouch Safety Hypodermic Needle
Applicant
Exelint International, Co.
2500 Santa Fe Ave.
Redondo Beach,  CA  90278
Applicant Contact Navid Hamid
Correspondent
Exelint International, Co.
2500 Santa Fe Ave.
Redondo Beach,  CA  90278
Correspondent Contact Navid Hamid
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/05/2015
Decision Date 11/02/2015
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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