FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOSKINS-BARKAN GONIOTOMY LENS 9MM
K Number: K875114
·
Decision Feb 19, 1988
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
40
Applicant Total
50
Review Days
67
Basic Information
- Device Name
- HOSKINS-BARKAN GONIOTOMY LENS 9MM
- K Number
- K875114
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- OCULAR INSTRUMENTS, INC.
- Date Received
- December 14, 1987
- Decision Date
- February 19, 1988
- Product Code
- HJK
- 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 |
|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | FDA class 2 | Ophthalmic |
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| K914051 | PEDIATRIC VITRECTOMY LENS SET | Dec 9, 1991 | Substantially Equivalent |
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