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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K183036
Device Name Dilator Sets
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 Number870.1310
Classification Product Code
DRE  
Subsequent Product Code
FGE  
Date Received11/01/2018
Decision Date 12/20/2018
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
Recalls CDRH Recalls
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