FDA 510(k) Application Details - DEN200063

Device Classification Name

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510(K) Number DEN200063
Device Name Kerasave
Applicant AL.CHI.MI.A. S.r.l
Viale Austria, 14
Ponte San Nicolo 35020 IT
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Contact Mauro Beccaro
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Regulation Number

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Classification Product Code QCW
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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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