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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 K963180
Device Name VIDAMED RF GENERATOR DATA RECORDER
Applicant
Vidamed, Inc.
1380 Willow Rd.Ve
Menlo Park,  CA  94025
Applicant Contact NOEL MESSENGER
Correspondent
Vidamed, Inc.
1380 Willow Rd.Ve
Menlo Park,  CA  94025
Correspondent Contact NOEL MESSENGER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/14/1996
Decision Date 10/10/1996
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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