AOSEPT DISINFECTANT
FDA premarket approval P820040/S033 · decided 1995-12-13
Approval details
- PMA number
- P820040
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AOSEPT DISINFECTANT
- Generic name
- Accessories, soft lens products
- Applicant
- Ciba Vision Care
- Date received
- 1995-07-27
- Decision date
- 1995-12-13
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
- Statement
- APPROVAL FOR LABELING MODIFICATIONS IN THE PACKAGE INSERT
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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 |