MINITHEERM
FDA premarket approval N18001/S005 · decided 1982-04-19
Approval details
- PMA number
- N18001
- Supplement
- S005
- Trade name
- MINITHEERM
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Ciba Vision Care
- Date received
- 1982-02-12
- Decision date
- 1982-04-19
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PROFESSIONAL DISINFECTION SYSTEM (PDS) (K863346) | Ciba Vision Care | 1987-02-27 |
| IN A WINK LUBRICATING & REWETTING DROPS (K853445) | Ciba Vision Care | 1985-11-29 |