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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 K050488
Device Name TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
Applicant
Prosurg, Inc.
2193 Trade Zone Blvd.
San Jose,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
Prosurg, Inc.
2193 Trade Zone Blvd.
San Jose,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number876.4300
Classification Product Code
FAS  
Date Received02/25/2005
Decision Date 04/01/2005
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
Predetermined Change
Control Plan Authorized		 No
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