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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 K012758
Device Name URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
Applicant
CIRCON VIDEO
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Applicant Contact WAYNE STERNER
Correspondent
CIRCON VIDEO
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Correspondent Contact WAYNE STERNER
Regulation Number876.1500
Classification Product Code
FGB  
Date Received08/17/2001
Decision Date 04/09/2002
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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