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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K101877
Device Name OCCLUSION BALLOON CATHETER MODEL OBC
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact LISA WEBB
Correspondent
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact LISA WEBB
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/06/2010
Decision Date 08/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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