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510(k) K090889

EMSI GARMENT ELECTRODES by Emsi — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2009
Date Received
March 31, 2009
Clearance Type
Traditional
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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  • K071869 — TENS/IF 14 (March 7, 2008)

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