Device Classification Name |
laser, surgical, gynecologic
|
510(k) Number |
K854361 |
Device Name |
CO2 LASER LAPAROSCOPE SYSTEM |
Applicant |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
7046 LYNDON AVE. |
ROSEMONT,
IL
60018
|
|
Applicant Contact |
CHARLES P GILL |
Correspondent |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
7046 LYNDON AVE. |
ROSEMONT,
IL
60018
|
|
Correspondent Contact |
CHARLES P GILL |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 10/29/1985 |
Decision Date | 02/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|