Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K014166 |
Device Name |
UHI-3 HIGH FLOW INSUFFLATION UNIT |
Applicant |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 12/19/2001 |
Decision Date | 06/25/2002 |
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
|
|
|