EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
FDA 510(k) clearance K142877 · decided 2015-03-13
Clearance details
- K-number
- K142877
- Device name
- EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
- Applicant
- Dutch Ophthalmic Research Center International BV
- Decision
- Substantially Equivalent
- Date received
- 2014-10-01
- Decision date
- 2015-03-13
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Zuidland, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.