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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 K052003
Device Name VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)
Applicant
Vnus Medical Technologies, Inc.
750 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact SAM NANAVATI
Correspondent
Vnus Medical Technologies, Inc.
750 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact SAM NANAVATI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/25/2005
Decision Date 10/11/2005
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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