KONTUR SOFT (METHAFILCON A) LENS
FDA premarket approval P850078/S002 · decided 1986-09-29
Approval details
- PMA number
- P850078
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KONTUR SOFT (METHAFILCON A) LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Kontur Kontact Lens Co., Inc.
- Date received
- 1986-08-04
- Decision date
- 1986-09-29
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hercules, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| KONTUR 55 SOFT LENS (K001908) | Kontur Kontact Lens Co., Inc. | 2000-08-18 |