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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K182252
Device Name Cook Unimpregnated Central Venous Catheter
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Johnathan Liu
Correspondent
Cook Incorporated
750 Daniels Way
P.Box 489
Bloomington,  IN  47402
Correspondent Contact Chelsea Woods
Regulation Number880.5200
Classification Product Code
FOZ  
Subsequent Product Code
DRE  
Date Received08/20/2018
Decision Date 05/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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