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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal
510(k) Number K853274
Device Name AMERICAN DILATATION SYSTEM
Applicant
American Endoscopy, Inc.
9350 Progress Pkwy.
Mentor,  OH  44060
Applicant Contact MARLIN E YOUNKER
Correspondent
American Endoscopy, Inc.
9350 Progress Pkwy.
Mentor,  OH  44060
Correspondent Contact MARLIN E YOUNKER
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received08/05/1985
Decision Date 10/17/1985
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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