Device Classification Name |
laser, surgical, gynecologic
|
510(k) Number |
K872253 |
Device Name |
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA |
Applicant |
SURGICAL LASER TECHNOLOGIES, INC. |
ONE GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
GIFFORD, R.N. |
Correspondent |
SURGICAL LASER TECHNOLOGIES, INC. |
ONE GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
GIFFORD, R.N. |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 05/20/1987 |
Decision Date | 10/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|