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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 K853530
Device Name ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
Applicant
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Applicant Contact JACK T BERGER
Correspondent
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Correspondent Contact JACK T BERGER
Regulation Number876.1500
Classification Product Code
FDX  
Date Received08/23/1985
Decision Date 10/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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