S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k) clearance K040900 · decided 2004-06-15
Clearance details
- K-number
- K040900
- Device name
- S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- Applicant
- Optical Connection, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-06
- Decision date
- 2004-06-15
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Felton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.