Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K945583 |
Device Name |
OCUSYSTEM(ART) |
Applicant |
ARENT FOX |
1050 CONNECTICUT AVE. N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
WAYNE H MATELSKI |
Correspondent |
ARENT FOX |
1050 CONNECTICUT AVE. N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
WAYNE H MATELSKI |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 11/14/1994 |
Decision Date | 02/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|