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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K030551
Device Name ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS
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 Number878.4400
Classification Product Code
GEI  
Date Received02/21/2003
Decision Date 03/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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