FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Accessories, Soft Lens Products
PMA: N16993
·
Supplement: S007
·
Decision Oct 26, 1981
Classifications
1
FEI Numbers
36
Registration Numbers
36
Basic Information
- Device Name
- Accessories, Soft Lens Products
- Trade Name
- ADAPPTE ARTIFICIAL TEAR
- PMA Number
- N16993
- Supplement Number
- S007
- Device Class
- FDA Class 2
- Product Code
- LPN
- Generic Name
- Accessories, soft lens products
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 26, 1981
- Date Received
- July 14, 1981
- 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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |