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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 K131204
Device Name ADVANCE CS CORONARY SINUS INFUSION CATHETER
Applicant
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Applicant Contact JENNIFER RICHARDSON
Correspondent
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Correspondent Contact JENNIFER RICHARDSON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/29/2013
Decision Date 01/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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