FDA 510(k)
FDA unclassified
Substantially Equivalent
🇮🇹 Italy
Eusol-C
K Number: K162013
·
Decision Sep 15, 2016
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
20
Applicant Total
3
Review Days
56
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Basic Information
- Device Name
- Eusol-C
- K Number
- K162013
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Al.Chi.Mi.A. S.R.L
- Date Received
- July 21, 2016
- Decision Date
- September 15, 2016
- Product Code
- LYX
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LYX | Media, Corneal Storage | FDA unclassified | Unknown |
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