Device Classification Name |
unit, phacofragmentation
|
510(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) |
B.V. |
Scheijdelveweg 2 |
Zuidland,
NL
3214 VN
|
|
Applicant Contact |
Linda Van Leeuwen |
Correspondent |
D.O.R.C. Dutch Ophthalmic Research Center (International) |
B.V. |
Scheijdelveweg 2 |
Zuidland,
NL
3214 VN
|
|
Correspondent Contact |
Linda Van Leeuwen |
Regulation Number | 886.4670
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/04/2019 |
Decision Date | 09/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|