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FDA 510(k) Application Details - K182112
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K182112
Device Name
Electrode, Cutaneous
Applicant
Infinite Biomedical Technologies, LLC
8 Market Place, Suite 500
Baltimore, MD 21202 US
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Contact
Rahul Kaliki
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
08/06/2018
Decision Date
10/05/2018
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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