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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 K191163
Device Name Lumax Guiding Catheter
Applicant
Cook Incorporated
750 Daniels Way
bloomington,  IN  47404
Applicant Contact david lehr
Correspondent
Cook Incorporated
750 Daniels Way
bloomington,  IN  47404
Correspondent Contact david lehr
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/01/2019
Decision Date 12/12/2019
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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