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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 K905731
Device Name FLEXIBLE ENDOSCOPIC ELECTRODE
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 Number876.4300
Classification Product Code
FAS  
Date Received12/24/1990
Decision Date 01/31/1991
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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