OXYCON LENS
FDA 510(k) clearance K990895 · decided 1999-04-14
Clearance details
- K-number
- K990895
- Device name
- OXYCON LENS
- Applicant
- Concise Contact Lens Co.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-17
- Decision date
- 1999-04-14
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.