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FDA 510(k) Application Details - K211868
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K211868
Device Name
Device,Analysis,Anterior Segment
Applicant
VISIA imaging S.R.L.
Via Martiri della Libertα, 95/e
San Giovanni Valdarno 52027 IT
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Contact
Alessia Magnanini
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2021
Decision Date
03/01/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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