Home / 510(k) Clearances / K190875

510(k) K190875

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) by D.O.R.C. Dutch Ophthalmic Research Center (International) — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2019
Date Received
April 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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