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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 K770913
Device Name UROLOGICAL BIOPSY BRUSH SET
Original Applicant
COOK, INC.
Regulation Number876.1500
Classification Product Code
FDX  
Date Received05/19/1977
Decision Date 06/01/1977
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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