FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
LUNEAU 3 MIRROR LENS
K Number: K022413
·
Decision Sep 24, 2002
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
40
Applicant Total
3
Review Days
62
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Basic Information
- Device Name
- LUNEAU 3 MIRROR LENS
- K Number
- K022413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Luneau SA
- Date Received
- July 24, 2002
- Decision Date
- September 24, 2002
- Product Code
- HJK
- 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 |
|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | FDA class 2 | Ophthalmic |
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