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510(k) K120494

DISPOSABLE ADHESIVE SURFACE ELECTRODE by Spes Medica Srl — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2012
Date Received
February 17, 2012
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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