IGEL 67 CONTACT LENS
FDA premarket approval P860009/S002 · decided 1989-05-09
Approval details
- PMA number
- P860009
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IGEL 67 CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Contamac, Ltd.
- Date received
- 1989-01-06
- Decision date
- 1989-05-09
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Essex
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (K212631) | Contamac, Ltd. | 2022-03-17 |
| Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304) | Contamac, Ltd. | 2018-11-23 |
| Nutrifill (K181566) | Contamac, Ltd. | 2018-10-22 |
| OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (K180616) | Contamac, Ltd. | 2018-04-25 |
| ENFLU 18 (enflufocon A) Daily Wear Contact Lens (K171575) | Contamac, Ltd. | 2017-10-24 |
| HEXA100 (hexafocon A) Daily Wear Contact Lenses (K171077) | Contamac, Ltd. | 2017-08-01 |
| Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (K161100) | Contamac, Ltd. | 2016-08-10 |
| OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (K160859) | Contamac, Ltd. | 2016-07-13 |