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510(k) Data Aggregation
K Number
K980171Device Name
DERMASENSE PLUS DISPERSIVE ELECTRODE
Manufacturer
Date Cleared
1998-02-27
(38 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
HORIZON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A NEUIRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR.
Device Description
DermaSense PLUS Dispersive Electrode is a disposable, single use device commonly referred to in the industry as a neutral electrode, patient plate, or return electrode. A split, dual conductive plate design allows this device to be used with Return Electrode Monitor (REM) systems found on most electorsurgical generators being marketed today.
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