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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 K183526
Device Name Codman Electrosurgical Generator, Foot Pedal
Applicant
Kls Martin GmbH + Co. KG
Am Flughafen 18
Freiburg Im Breisgau,  DE 79108
Applicant Contact Hanna Huttmeyer
Correspondent
Kls Martin GmbH + Co. KG
Am Flughafen 18
Freiburg Im Breisgau,  DE 79108
Correspondent Contact Hanna Huttmeyer
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/19/2018
Decision Date 04/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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