FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
FDA 510(k) clearance K003586 · decided 2001-02-08
Clearance details
- K-number
- K003586
- Device name
- FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
- Applicant
- Ciba-Geigy Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-20
- Decision date
- 2001-02-08
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- MVN
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Duluth, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IN A WINK CLEANING SOLUTION (P870005/S003) | Ciba-Geigy Corp. | 1989-07-31 |
| IN A WINK CLEANING SOLUTION (P870005/S001) | Ciba-Geigy Corp. | 1988-12-28 |