IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1
FDA 510(k) clearance K060905 · decided 2006-05-31
Clearance details
- K-number
- K060905
- Device name
- IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1
- Applicant
- Iridex Corp
- Decision
- Substantially Equivalent
- Date received
- 2006-04-03
- Decision date
- 2006-05-31
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.