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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 K031029
Device Name ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
Applicant
ARTHROCARE CORP.
680 VAQUEROS AVE.
SUNNYVALE,  CA  94085 -3523
Applicant Contact VALERIE DEFIESTA-NG
Correspondent
ARTHROCARE CORP.
680 VAQUEROS AVE.
SUNNYVALE,  CA  94085 -3523
Correspondent Contact VALERIE DEFIESTA-NG
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
KNS  
Date Received04/01/2003
Decision Date 06/19/2003
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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