SILIKON 1000
FDA premarket approval P950008/S006 · decided 2003-12-22
Approval details
- PMA number
- P950008
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SILIKON 1000
- Generic name
- Fluid, intraocular
- Applicant
- Alcon
- Date received
- 2003-12-15
- Decision date
- 2003-12-22
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR THE FINISHED PRODUCT VISCOSITY RANGE, I.E., FROM THE RANGE OF 900 TO 1200 CS TO THE RANG OF 900 TO 1250 CS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ALCON VISION SYSTEM (K063583) | Alcon | 2008-05-09 |
| OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION (K981574) | Alcon | 1998-07-06 |