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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 K122917
Device Name CODA BALLOON CATHETER
Applicant
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact ELYSIA EASTON
Correspondent
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact ELYSIA EASTON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/25/2012
Decision Date 06/28/2013
Decision Substantially Equivalent (SESE)
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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