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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K940982
Device Name ARTERIAL EMBOLIZATION DEVICE (KRD)
Applicant
Cook, Inc.
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number870.3300
Classification Product Code
KRD  
Date Received03/01/1994
Decision Date 10/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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