FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
ONEUSE- PLUS MICROKERATOME
K Number: K040297
·
Decision Mar 31, 2004
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
11
Applicant Total
5
Review Days
51
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Basic Information
- Device Name
- ONEUSE- PLUS MICROKERATOME
- K Number
- K040297
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Moria SA
- Date Received
- February 9, 2004
- Decision Date
- March 31, 2004
- Product Code
- HMY
- 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 |
|---|---|---|---|
| HMY | Keratome, Battery-Powered | FDA class 1 | Ophthalmic |
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