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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 K971532
Device Name ARTHROCARE ELECTROSURGERY SYSTEM
Applicant
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Applicant Contact CHERYL SHEA
Correspondent
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Correspondent Contact CHERYL SHEA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/28/1997
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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