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FDA 510(k) Application Details - K200203
Device Classification Name
More FDA Info for this Device
510(K) Number
K200203
Device Name
Infrascanner
Applicant
InfraScan, Inc.
3508 Market Street
Philadelphia, PA 19104 US
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Contact
Baruch Ben Dor
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OPT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/28/2020
Decision Date
07/10/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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