FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORNEAL MODELING SYSTEM
K Number: K862379
·
Decision Aug 25, 1986
Classifications
1
FEI Numbers
56
Registration Numbers
57
Same Product Code
106
Applicant Total
4
Review Days
62
Basic Information
- Device Name
- CORNEAL MODELING SYSTEM
- K Number
- K862379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- COMPUTED ANATOMY, INC.
- Date Received
- June 24, 1986
- Decision Date
- August 25, 1986
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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