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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 K031079
Device Name EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
Applicant
Gyrus Medical, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55311
Applicant Contact MERCEDES BAYANI
Correspondent
Gyrus Medical, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55311
Correspondent Contact MERCEDES BAYANI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/04/2003
Decision Date 05/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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