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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 K012929
Device Name FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
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
FAJ  
Date Received08/31/2001
Decision Date 11/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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