Device Classification Name |
Laser, Surgical, Gynecologic
|
510(k) Number |
K863361 |
Device Name |
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA |
Applicant |
COOPER LASERSONICS, INC. |
3420 Central Expressway |
Santa Clara,
CA
95051
|
|
Applicant Contact |
CHARLES L ROSE |
Correspondent |
COOPER LASERSONICS, INC. |
3420 Central Expressway |
Santa Clara,
CA
95051
|
|
Correspondent Contact |
CHARLES L ROSE |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 09/02/1986 |
Decision Date | 11/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|