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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral, Mechanical
510(k) Number K831384
Device Name COAXIAL BALLOON URETHRAL 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 Number876.5520
Classification Product Code
FAH  
Date Received04/28/1983
Decision Date 07/26/1983
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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