MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
FDA 510(k) clearance K052606 · decided 2005-12-15
Clearance details
- K-number
- K052606
- Device name
- MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
- Applicant
- Marietta Vision
- Decision
- Substantially Equivalent
- Date received
- 2005-09-22
- Decision date
- 2005-12-15
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.