Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K081173 |
Device Name |
ENDOSCOPIC CO2 REGULATION UNIT UCR |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 04/24/2008 |
Decision Date | 12/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|