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FDA 510(k) Application Details - K171581
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K171581
Device Name
Electrode, Depth
Applicant
Alpha Omega Engineering Ltd,
Nazareth Industrial Park, Mount Precipice, St.2015
Nazareth 1612102 IL
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Contact
Maysana Mousa
Other 510(k) Applications for this Contact
Regulation Number
882.1330
More FDA Info for this Regulation Number
Classification Product Code
GZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/31/2017
Decision Date
12/22/2017
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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