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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 K981870
Device Name VISAGE COSMETIC SURGERY SYSTEM
Applicant
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact Mark Smutka
Correspondent
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact Mark Smutka
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/28/1998
Decision Date 08/20/1998
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
Predetermined Change
Control Plan Authorized		 No
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