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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 K965118
Device Name ENDOCARE MONOPOLAR ELECTRODE
Applicant
ENDOCARE, INC.
18 TECHNOLOGY DR., SUITE 134
IRVINE,  CA  92718
Applicant Contact VIN CUTARELLI
Correspondent
ENDOCARE, INC.
18 TECHNOLOGY DR., SUITE 134
IRVINE,  CA  92718
Correspondent Contact VIN CUTARELLI
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
GEI  
Date Received12/20/1996
Decision Date 02/25/1997
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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