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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 K003624
Device Name REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702
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 Number878.4400
Classification Product Code
GEI  
Date Received11/24/2000
Decision Date 12/20/2000
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
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