Device Classification Name |
laser, surgical, gynecologic
|
510(k) Number |
K875314 |
Device Name |
GL-35 COLPOSCOPIC LASER SYSTEM |
Applicant |
LASER ENGINEERING, INC. |
113 CEDAR ST. |
MILFORD,
MA
01757
|
|
Applicant Contact |
ROBERT I RUDKO |
Correspondent |
LASER ENGINEERING, INC. |
113 CEDAR ST. |
MILFORD,
MA
01757
|
|
Correspondent Contact |
ROBERT I RUDKO |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 12/29/1987 |
Decision Date | 08/05/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|