FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
M2 SINGLE USE MICROKERTOME
K Number: K022560
·
Decision Sep 27, 2002
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
11
Applicant Total
5
Review Days
56
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Basic Information
- Device Name
- M2 SINGLE USE MICROKERTOME
- K Number
- K022560
- 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
- August 2, 2002
- Decision Date
- September 27, 2002
- 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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