FDA PMA
FDA Class 3
🇺🇸 United States
Lenses, Soft Contact, Extended Wear
PMA: P810005
·
Decision Sep 24, 1981
Classifications
1
FEI Numbers
56
Registration Numbers
56
Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
- PMA Number
- P810005
- Device Class
- FDA Class 3
- Product Code
- LPM
- Generic Name
- Lenses, soft contact, extended wear
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision Code
- APCB
- Decision Date
- September 24, 1981
- Date Received
- February 20, 1981
- Expedited Review
- N
- Docket Number
- 81M-0317
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 |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | FDA class 3 | Ophthalmic |