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FDA 510(k) Application Details - K181544
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K181544
Device Name
Electrode, Depth
Applicant
Ad-Tech Medical Instrument Corporation
400 West Oakwood Road
Oak Creek, WI 53154 US
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Contact
Lisa Theama
Other 510(k) Applications for this Contact
Regulation Number
882.1330
More FDA Info for this Regulation Number
Classification Product Code
GZL
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More FDA Info for this Product Code
Date Received
06/12/2018
Decision Date
08/09/2018
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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