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FDA 510(k) Application Details - K162013
Device Classification Name
Media, Corneal Storage
More FDA Info for this Device
510(K) Number
K162013
Device Name
Media, Corneal Storage
Applicant
AL.CHI.MI.A. S.r.l.
Viale Austria 14
Ponte San Nicolo 35020 IT
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Contact
Mauro Beccaro
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LYX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/21/2016
Decision Date
09/15/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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