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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K181351
Device Name Double Flexible Tipped Wire Guides
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Applicant Contact Jennifer Allman
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Correspondent Contact Jennifer Allman
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/22/2018
Decision Date 06/14/2018
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
Recalls CDRH Recalls
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