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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K924103
Device Name CLEANING BRUSH
Applicant
United States Endoscopy Group, Inc.
9905 Hobart Rd.
Waite Hill,  OH  44094
Applicant Contact MARLIN YOUNKER
Correspondent
United States Endoscopy Group, Inc.
9905 Hobart Rd.
Waite Hill,  OH  44094
Correspondent Contact MARLIN YOUNKER
Regulation Number876.1500
Classification Product Code
FEB  
Date Received08/13/1992
Decision Date 11/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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