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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K023116
Device Name CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
Applicant
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number870.3375
Classification Product Code
DTK  
Date Received09/19/2002
Decision Date 10/18/2002
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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