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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic cytology brush
510(k) Number K182231
Device Name Brush Biopsy Set ; Deflectable Brush Biopsy Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Thomas Palmer
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Chelsea Woods
Regulation Number876.1500
Classification Product Code
FDX  
Subsequent Product Code
KOD  
Date Received08/17/2018
Decision Date 05/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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