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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 K003092
Device Name MODIFICATION TO VNUS CLOSURE SYSTEM
Applicant
Vnus Medical Technologies, Inc.
238 E. Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact SAM NANAVATI
Correspondent
Vnus Medical Technologies, Inc.
238 E. Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact SAM NANAVATI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/03/2000
Decision Date 12/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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