FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Solution, Cleaning / Lubricating, Artificial Eye
PMA: N13787
·
Decision Mar 26, 1997
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Solution, Cleaning / Lubricating, Artificial Eye
- Trade Name
- ENUCLENE CLEANING/LUBRICATING SOLUTION
- PMA Number
- N13787
- Device Class
- FDA Class 3
- Product Code
- MSI
- Generic Name
- Solution, cleaning / lubricating, artificial eye
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- March 26, 1997
- Date Received
- April 6, 1964
- Expedited Review
- N
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 |
|---|---|---|---|
| MSI | Solution, Cleaning / Lubricating, Artificial Eye | FDA class 3 | Unknown |