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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K915219
Device Name URETHRAL ELECTRODE SHEATH
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
Correspodent Contact jo stegwell
Regulation Number876.4300
Classification Product Code
FAS  
Date Received11/20/1991
Decision Date 07/23/1992
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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