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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 K163106
Device Name CODMAN Integrated Bipolar Cord and Tubing Set
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Megan Palumbo
Correspondent
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Correspondent Contact Megan Palumbo
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/07/2016
Decision Date 12/01/2016
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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