CODMAN Integrated Bipolar Cord And Tubing Set

Electrosurgical, Cutting & Coagulation & Accessories

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Codman Integrated Bipolar Cord And Tubing Set.

Pre-market Notification Details

Device IDK163106
510k NumberK163106
Device Name:CODMAN Integrated Bipolar Cord And Tubing Set
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Medos International SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactMegan Palumbo
CorrespondentMegan Palumbo
Medos International SARL Chemin-Blanc 38 Le Locle,  CH 2400
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-07
Decision Date2016-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886704080531 K163106 000
00381780521740 K163106 000
00381780521757 K163106 000
00381780521764 K163106 000
00381780521771 K163106 000
00381780521788 K163106 000
20886704080487 K163106 000
20886704080494 K163106 000
20886704080500 K163106 000
20886704080517 K163106 000
20886704080524 K163106 000
00381780521733 K163106 000

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