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FDA 510(k) Application Details - K172703
Device Classification Name
Electrode, Cutaneous
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510(K) Number
K172703
Device Name
Electrode, Cutaneous
Applicant
Embla Systems
1 Hines Road, Suite 202
Kanata K2K 3C7 CA
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Contact
Sanjay Mehta
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Regulation Number
882.1320
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Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
09/07/2017
Decision Date
11/13/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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