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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K010568
Device Name ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
Applicant
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Applicant Contact BETTY M JOHNSON
Correspondent
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Correspondent Contact BETTY M JOHNSON
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
FAS  
Date Received02/26/2001
Decision Date 03/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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