EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
FDA 510(k) clearance K190875 · decided 2019-09-25
Clearance details
- K-number
- K190875
- Device name
- EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
- Applicant
- D.O.R.C. Dutch Ophthalmic Research Center (International)
- Decision
- Substantially Equivalent
- Date received
- 2019-04-04
- Decision date
- 2019-09-25
- Days to decision
- 174 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.