Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K833465 |
Device Name |
DISPOSABLE FIBER OPTIC ILLUMINATOR |
Applicant |
COOPERVISION, INC. |
PERMALENS HOUSE |
1 BOTLEY ROAD, HEDGE END |
SOUTHAMPTON,
GB
S033HB
|
|
Correspondent |
COOPERVISION, INC. |
PERMALENS HOUSE |
1 BOTLEY ROAD, HEDGE END |
SOUTHAMPTON,
GB
S033HB
|
|
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 10/05/1983 |
Decision Date | 03/15/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|