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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 K964482
Device Name FLEXIBLE URETEROSCOPE
Applicant
APPLIED FIBEROPTICS, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Applicant Contact GRAHAM BAILLIE
Correspondent
APPLIED FIBEROPTICS, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Correspondent Contact GRAHAM BAILLIE
Regulation Number876.1500
Classification Product Code
FGB  
Date Received11/08/1996
Decision Date 01/24/1997
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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