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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 K103032
Device Name ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
Applicant
Olympus Winter & Ibe GmbH
3500 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
Olympus Winter & Ibe GmbH
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact STACY ABBATIELLO KLUESNER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/12/2010
Decision Date 01/14/2011
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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