FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
CARRIAZO BARRAQUER MICROKERATOME
K Number: K981741
·
Decision Jul 24, 1998
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
11
Applicant Total
4
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARRIAZO BARRAQUER MICROKERATOME
- K Number
- K981741
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Moria, Inc.
- Date Received
- May 18, 1998
- Decision Date
- July 24, 1998
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMY), ordered by most recent decision date.
ONEUSE- PLUS MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
BD K-4000 MICROKERATOME SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
M2 SINGLE USE MICROKERTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
CARRIAZO BARRAQUER II MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic