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FDA 510(k) Application Details - K171798
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K171798
Device Name
Electrode, Cutaneous
Applicant
Media Plus, LLC
560 Sylvan Aveue, 3rd Floor
Englewood Cliffs, NJ 07632 US
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Contact
Rita Vacco
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2017
Decision Date
06/01/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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