Device Classification Name |
Unit, Phacofragmentation
|
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) |
Applicant |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
SCHEIJDELVEWEG 2 |
ZUIDLAND,
NL
3214 VN
|
|
Applicant Contact |
DANIELLE SLEEGERS |
Correspondent |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
SCHEIJDELVEWEG 2 |
ZUIDLAND,
NL
3214 VN
|
|
Correspondent Contact |
DANIELLE SLEEGERS |
Regulation Number | 886.4670
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/01/2014 |
Decision Date | 03/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|