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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K011325
Device Name MEDIFIX URETEROSCOPE
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
FGB  
Date Received05/01/2001
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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