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510(k) K091410

DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, by Spes Medica Srl — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2009
Date Received
May 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

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