FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
EZYPOR
K Number: K212741
·
Decision Jun 24, 2022
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
38
Applicant Total
4
Review Days
298
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Basic Information
- Device Name
- EZYPOR
- K Number
- K212741
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fci (France Chirurgie Instrumentation) Sas
- Date Received
- August 30, 2021
- Decision Date
- June 24, 2022
- Product Code
- HPZ
- 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
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