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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 K010404
Device Name EXEL I.V. ADMINISTRATION SET
Applicant
Exelint Intl. Co.
P.O. Box 3194
Culver City,  CA  90231
Applicant Contact ARMAND HAMID
Correspondent
Exelint Intl. Co.
P.O. Box 3194
Culver City,  CA  90231
Correspondent Contact ARMAND HAMID
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/12/2001
Decision Date 08/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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