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FDA 510(k), K142877, EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
FDA 510(k), K142877, EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
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510(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)
Manufacturer: DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
Device Classification Name: unit, phacofragmentation
Regulation Number: 886.4670
Classification Product Code: HQC
Date Received: 10/01/2014
Decision Date: 03/13/2015
Regulation Medical Specialty: Ophthalmic
Device Name: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
Manufacturer: DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
Device Classification Name: unit, phacofragmentation
Regulation Number: 886.4670
Classification Product Code: HQC
Date Received: 10/01/2014
Decision Date: 03/13/2015
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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