OTI MODEL 78-60
FDA 510(k) clearance K951184 · decided 1995-05-12
Clearance details
- K-number
- K951184
- Device name
- OTI MODEL 78-60
- Applicant
- Oti Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 1995-03-16
- Decision date
- 1995-05-12
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- HJO
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.