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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 K973820
Device Name USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
Applicant
CIRCON CORP.
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Applicant Contact ANDREW D SIMONS
Correspondent
CIRCON CORP.
6500 HOLLISTER AVE.
SANTA BARBARA,  CA  93117 -3019
Correspondent Contact ANDREW D SIMONS
Regulation Number876.4300
Classification Product Code
FAS  
Date Received10/07/1997
Decision Date 05/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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