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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 K021364
Device Name MODIFICATION TO ENTEC PLASMA 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 Received04/30/2002
Decision Date 05/30/2002
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
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