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510(k) K173186

S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D by Everyway Medical Instruments Co.,Ltd — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2018
Date Received
October 2, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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