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FDA 510(k) Application Details - K221601
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K221601
Device Name
Device,Analysis,Anterior Segment
Applicant
C.S.O. S.r.l.
Via degli Stagnacci, 12/E
Scandicci 50018 IT
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Contact
Gilda Mura
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
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More FDA Info for this Product Code
Date Received
06/02/2022
Decision Date
09/01/2023
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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