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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K992039
Device Name EXEL I.V. BLOOD LINE 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 Number876.5820
Classification Product Code
FJK  
Date Received06/17/1999
Decision Date 02/10/2000
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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