510(k) DEN200063
- Device
- Kerasave
- Applicant
- Al.Chi.Mi.A. S.R.L
- 510(k) number
- DEN200063
- Product code
- QCW
- Decision
- Unknown (DENG)
- Decision date
- 2022-05-02
- Date received
- 2020-10-01
- Regulation
- 886.4320
- Classification name
- Corneal Storage Media With Preservatives Including Anti-Fungal
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mauro Beccaro
- Address
- Viale Austria, 14 Ponte San Nicolò IT 35020 35020
FDA Registration Numbers#
- 3004471819
Source Documents#
510(k) summary PDF not indicated by FDA