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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 K841310
Device Name GASTROINTESTINAL DILATOR
Applicant
Thomas J. Fogarty, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Thomas J. Fogarty, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received03/30/1984
Decision Date 07/31/1984
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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