FDA 510(k)
FDA class 2
Unknown
🇮🇹 Italy
Kerasave
K Number: DEN200063
·
Decision May 2, 2022
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
578
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Basic Information
- Device Name
- Kerasave
- K Number
- DEN200063
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 886.4320
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Applicant
- Al.Chi.Mi.A. S.R.L
- Date Received
- October 1, 2020
- Decision Date
- May 2, 2022
- Product Code
- QCW
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCW | Corneal Storage Media With Preservatives Including Anti-Fungal | FDA class 2 | Ophthalmic |