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510(k) K192603

Spes Medica Subdermal Needle Electrodes by Spes Medica Srl — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2019
Date Received
September 20, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

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