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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 K901214
Device Name RIGID URETEROSCOPE
Applicant
APPLIED UROLOGY, INC.
26051 MERIT CIRCLE, BLDG. 104
LAGUNA HILLS,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
APPLIED UROLOGY, INC.
26051 MERIT CIRCLE, BLDG. 104
LAGUNA HILLS,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number876.1500
Classification Product Code
FGB  
Date Received03/14/1990
Decision Date 06/01/1990
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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