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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 K080610
Device Name ARTHROCARE ORTHOWAND SURGICAL DEVICE
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 Received03/04/2008
Decision Date 03/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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