FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
CENTURION SES EPIKERATOME
K Number: K042810
·
Decision Oct 28, 2004
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
4
Review Days
16
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Basic Information
- Device Name
- CENTURION SES EPIKERATOME
- K Number
- K042810
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Norwood Abbey , Ltd.
- Date Received
- October 12, 2004
- Decision Date
- October 28, 2004
- Product Code
- HNO
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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