Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K031014 |
Device Name |
HI-FLO THERME PNEU 45, WISAP #7083, 7083V |
Applicant |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
RUDOLF-DIESEL-RING 20 |
SAUERLACH,
DE
D-82054
|
|
Applicant Contact |
HORST SEMM |
Correspondent |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
RUDOLF-DIESEL-RING 20 |
SAUERLACH,
DE
D-82054
|
|
Correspondent Contact |
HORST SEMM |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 03/31/2003 |
Decision Date | 06/27/2003 |
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
|
|
|