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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K133114
Device Name MICROPUNCTURE INTRODUCER SET
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact DAVID LEHR, RAC
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact DAVID LEHR, RAC
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/30/2013
Decision Date 07/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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