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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 K000511
Device Name MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS
Applicant
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact BRUCE PROTHRO
Correspondent
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact BRUCE PROTHRO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/16/2000
Decision Date 03/13/2000
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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