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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 K132592
Device Name FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
Applicant
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Applicant Contact DAVID LEHR
Correspondent
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Correspondent Contact DAVID LEHR
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/19/2013
Decision Date 10/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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