Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K081877 |
Device Name |
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS |
Applicant |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
SCHEIJDELVEG 2 |
ZUIDLAND,
NL
3214 VN
|
|
Applicant Contact |
GER VIJFVINKEL |
Correspondent |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
SCHEIJDELVEG 2 |
ZUIDLAND,
NL
3214 VN
|
|
Correspondent Contact |
GER VIJFVINKEL |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/02/2008 |
Decision Date | 01/05/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|