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510(k) DEN120019

CEFALY by Stx-Med Sprl — Product Code PCC

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 11, 2014
Date Received
December 13, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class
Class II
Regulation Number
882.5891
Review Panel
NE
Submission Type

Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

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