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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K092172
Device Name EXEL I.V. EXTENSION SET
Applicant
Exelint Intl. Co.
5840 W. Centinela Ave.
Los Angeles,  CA  90045
Applicant Contact ARMAND HAMID
Correspondent
Exelint Intl. Co.
5840 W. Centinela Ave.
Los Angeles,  CA  90045
Correspondent Contact ARMAND HAMID
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/21/2009
Decision Date 01/04/2010
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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