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FDA 510(k) Application Details - K190735
Device Classification Name
Apparatus, Vestibular Analysis
More FDA Info for this Device
510(K) Number
K190735
Device Name
Apparatus, Vestibular Analysis
Applicant
Highmark Innovations Inc. DBA Highmark Interactive
1 University Avenue, 3rd Floor
Toronto M5J 2Pl CA
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Contact
Dave Crane
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LXV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2019
Decision Date
08/16/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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