FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Intraocular Lens
PMA: P870045
·
Decision Jan 24, 1990
Classifications
1
FEI Numbers
59
Registration Numbers
59
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- SK15 AND SK16
- PMA Number
- P870045
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- January 24, 1990
- Date Received
- July 28, 1987
- Expedited Review
- N
- Docket Number
- 90M-0053
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |