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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 K000062
Device Name CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
Applicant
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number870.3375
Classification Product Code
DTK  
Date Received01/10/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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