STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION
FDA premarket approval P890067/S001 · decided 1991-01-18
Approval details
- PMA number
- P890067
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Steridyne Laboratories, Inc.
- Date received
- 1990-08-16
- Decision date
- 1991-01-18
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hollywood, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. (K870430) | Steridyne Laboratories, Inc. | 1987-04-13 |
| GAUZE, ABSORBENT, IODOFORM IMPREGNATED (K870431) | Steridyne Laboratories, Inc. | 1987-02-26 |