FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
OPHTHALMIC STAND
K Number: K913961
·
Decision Dec 4, 1991
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
14
Applicant Total
3
Review Days
90
Basic Information
- Device Name
- OPHTHALMIC STAND
- K Number
- K913961
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1860
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LUNEAU OPHTALMOLOGIE SA
- Date Received
- September 5, 1991
- Decision Date
- December 4, 1991
- Product Code
- HMF
- 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 |
|---|---|---|---|
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | FDA class 1 | Ophthalmic |
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