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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K992483
Device Name MEDIFIX INC.
Applicant
MEDIFIX, INC.
8727 NARRAGANSETT
MORTON GROVE,  IL  60053 -0000
Applicant Contact GEORGE ALBULESCU
Correspondent
MEDIFIX, INC.
8727 NARRAGANSETT
MORTON GROVE,  IL  60053 -0000
Correspondent Contact GEORGE ALBULESCU
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received07/26/1999
Decision Date 08/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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