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FDA 510(k) Application Details - K190163
Device Classification Name
More FDA Info for this Device
510(K) Number
K190163
Device Name
ALARA Neuro Access Kit
Applicant
SurGenTec, LLC
7601 N Federal Highway #150A
Boca Raton, FL 33487 US
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Contact
Travis Greenhalgh
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Regulation Number
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Classification Product Code
PDQ
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Date Received
01/31/2019
Decision Date
07/16/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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