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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 K240589
Device Name Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
Applicant
Cook, Medical
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact David Lehr
Correspondent
Cook, Medical
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact David Lehr
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/01/2024
Decision Date 03/25/2024
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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