Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K941438 |
Device Name |
OP-PNEU ELECTRONIC CO2 |
Applicant |
WISAP/U.S.A. |
W-8029 SAUERLACH B. |
MUNCHEN,,
DE
|
|
Applicant Contact |
H. SEMM |
Correspondent |
WISAP/U.S.A. |
W-8029 SAUERLACH B. |
MUNCHEN,,
DE
|
|
Correspondent Contact |
H. SEMM |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 03/24/1994 |
Decision Date | 05/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|