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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 K031080
Device Name EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS
Applicant
GYRUS MEDICAL, INC.
6655 WEDGWOOD RD.
MINNEAPOLIS,  MN  55311 -3602
Applicant Contact MERCEDES BIRYANI
Correspondent
GYRUS MEDICAL, INC.
6655 WEDGWOOD RD.
MINNEAPOLIS,  MN  55311 -3602
Correspondent Contact MERCEDES BIRYANI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/04/2003
Decision Date 05/16/2003
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
Recalls CDRH Recalls
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