Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K854949 |
Device Name |
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS |
Applicant |
COOPERVISION, INC. |
LASER DIVISION |
3420 CENTRAL EXPRESSWAY |
SANTA CLARA,
CA
95051
|
|
Applicant Contact |
CHARLES L ROSE |
Correspondent |
COOPERVISION, INC. |
LASER DIVISION |
3420 CENTRAL EXPRESSWAY |
SANTA CLARA,
CA
95051
|
|
Correspondent Contact |
CHARLES L ROSE |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 12/10/1985 |
Decision Date | 02/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|