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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 AVENUE, SUITE 10
SACRAMENTO,  CA  95834 -5432
Applicant Contact BRIAN T CLEARY
Correspondent
POWER ANALYTICS CORP.
819 STRIKER AVENUE, SUITE 10
SACRAMENTO,  CA  95834 -5432
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
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