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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 K191485
Device Name Deflectable Brush Biopsy Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Irasema Rivera
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Irasema Rivera
Regulation Number876.1500
Classification Product Code
FDX  
Subsequent Product Code
KOD  
Date Received06/04/2019
Decision Date 06/26/2019
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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