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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 K992045
Device Name ELECTROSURGICAL ELECTRODE FAMILY
Applicant
Genesis Medical, Inc.
524 Weddel Dr., Suite 4
Sunnyvale,  CA  94089
Applicant Contact THOMAS WEHMAN
Correspondent
Genesis Medical, Inc.
524 Weddel Dr., Suite 4
Sunnyvale,  CA  94089
Correspondent Contact THOMAS WEHMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/17/1999
Decision Date 01/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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