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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 K080282
Device Name ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
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 Received02/04/2008
Decision Date 02/15/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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