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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 K951897
Device Name POWER RESECTOSCOPE CUTTING LOOP
Applicant
Power Analytics Corp.
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Applicant Contact BRIAN T CLEARY
Correspondent
Power Analytics Corp.
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Correspondent Contact BRIAN T CLEARY
Regulation Number876.4300
Classification Product Code
FAS  
Date Received04/24/1995
Decision Date 07/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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