EXPRESS MINI GLAUCOMA SHUNT
FDA 510(k) clearance K030350 · decided 2003-03-13
Clearance details
- K-number
- K030350
- Device name
- EXPRESS MINI GLAUCOMA SHUNT
- Applicant
- Optonol, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-03
- Decision date
- 2003-03-13
- Days to decision
- 38 days
- Clearance type
- Abbreviated
- Product code
- KYF
- Device class
- 2
- Regulation number
- 886.3920
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Duluth, GA, US
- Third-party review
- No
- Expedited review
- No
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| EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS (K012852) | Optonol, Ltd. | 2002-03-26 |
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Recalls involving this device
No recalls on record reference this clearance.