TRESOFT SOFT CONTACT LENSE
FDA premarket approval N17855/S006 · decided 1988-06-08
Approval details
- PMA number
- N17855
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRESOFT SOFT CONTACT LENSE
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Ciba Vision Care
- Date received
- 1987-11-24
- Decision date
- 1988-06-08
- Days to decision
- 197 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 |