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510(k) K103719

LIFECARE CONDUCTIVE GARMENTS by Everyway Medical Instruments Co.,Ltd — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2011
Date Received
December 21, 2010
Clearance Type
Abbreviated
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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