Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K942838 |
Device Name |
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN |
Applicant |
OLYMPUS AMERICA, INC. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042 -1179
|
|
Applicant Contact |
BARRY SANDS |
Correspondent |
OLYMPUS AMERICA, INC. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042 -1179
|
|
Correspondent Contact |
BARRY SANDS |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 06/15/1994 |
Decision Date | 10/31/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|