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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 K011757
Device Name EXEL COMFORTPOINT INSULIN PEN NEEDLE
Applicant
EXELINT INTL. CO.
P.O. BOX 3194
CULVER CITY,  CA  90231 -3194
Applicant Contact ARMAND HAMID
Correspondent
EXELINT INTL. CO.
P.O. BOX 3194
CULVER CITY,  CA  90231 -3194
Correspondent Contact ARMAND HAMID
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/06/2001
Decision Date 01/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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