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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 K924104
Device Name CYTOLOGY BRUSH
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Applicant Contact MARLIN YOUNKER
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Correspondent Contact MARLIN YOUNKER
Regulation Number876.1500
Classification Product Code
FDX  
Date Received08/13/1992
Decision Date 11/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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