Medline Patient Cables And Lead Wires

Cable, Transducer And Electrode, Patient, (including Connector)

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Patient Cables And Lead Wires.

Pre-market Notification Details

Device IDK181726
510k NumberK181726
Device Name:Medline Patient Cables And Lead Wires
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactDinah Rincones
CorrespondentDinah Rincones
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-29
Decision Date2018-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20888277697543 K181726 000

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