MOLTENO VALVE SETON
FDA 510(k) clearance K875099 · decided 1988-03-30
Clearance details
- K-number
- K875099
- Device name
- MOLTENO VALVE SETON
- Applicant
- Staar Surgical Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-10
- Decision date
- 1988-03-30
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- KYF
- Device class
- 2
- Regulation number
- 886.3920
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Monrovia, CA, US
- Third-party review
- No
- Expedited review
- No
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| EXPRESS MINI GLAUCOMA SHUNT (K030350) | Optonol, Ltd. | 2003-03-13 |
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Recalls involving this device
No recalls on record reference this clearance.