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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K013037
FOIA Releasable 510(k) K013037
Device Name EXCEL A.V FISUTAL NEEDLE 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 Number876.5540
Classification Product Code
FIE  
Date Received09/10/2001
Decision Date 12/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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