Device Classification Name |
marker, ocular
|
510(k) Number |
K861535 |
Device Name |
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU |
Applicant |
COOPERVISION, INC. |
COOPERVISION CILCO |
3190 160TH AVENUE S.E. |
BELLEVUE,
WA
98008
|
|
Applicant Contact |
MICHAEL J ANDREWS |
Correspondent |
COOPERVISION, INC. |
COOPERVISION CILCO |
3190 160TH AVENUE S.E. |
BELLEVUE,
WA
98008
|
|
Correspondent Contact |
MICHAEL J ANDREWS |
Regulation Number | 886.4570
|
Classification Product Code |
|
Date Received | 04/24/1986 |
Decision Date | 05/14/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|