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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 K982816
FOIA Releasable 510(k) K982816
Device Name VNUS CLOSURE SYSTEM
Applicant
Vnus Medical Technologies, Inc.
238 E. Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact JOHN D'ANGELO
Correspondent
Vnus Medical Technologies, Inc.
238 E. Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact JOHN D'ANGELO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/11/1998
Decision Date 03/17/1999
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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