Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K092984 |
Device Name |
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 |
Applicant |
Panpac Medical Corporation |
NO. 202, 6F-1.2, SEC.3 |
TATONG ROAD |
SHI-CHIH CITY, TAIPEI HSIEN,
TW
22103
|
|
Applicant Contact |
Yen-Ming Pan |
Correspondent |
Panpac Medical Corporation |
NO. 202, 6F-1.2, SEC.3 |
TATONG ROAD |
SHI-CHIH CITY, TAIPEI HSIEN,
TW
22103
|
|
Correspondent Contact |
Yen-Ming Pan |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/28/2009 |
Decision Date | 04/07/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|