Kerasave
FDA 510(k) clearance DEN200063 · decided 2022-05-02
Clearance details
- K-number
- DEN200063
- Device name
- Kerasave
- Applicant
- Al.Chi.Mi.A. S.R.L
- Decision
- Unknown
- Date received
- 2020-10-01
- Decision date
- 2022-05-02
- Days to decision
- 578 days
- Clearance type
- Post-NSE
- Product code
- QCW
- Device class
- 2
- Regulation number
- 886.4320
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Ponte San Nicolò, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.