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FDA 510(k) Application Details - DEN200063
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN200063
Device Name
Kerasave
Applicant
AL.CHI.MI.A. S.r.l
Viale Austria, 14
Ponte San Nicolo 35020 IT
Other 510(k) Applications for this Company
Contact
Mauro Beccaro
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QCW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2020
Decision Date
05/02/2022
Decision
DENG -
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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