Device Classification Name |
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
|
510(k) Number |
K881736 |
Device Name |
SURGITEK CO2 DELIVERY SYSTEM |
Applicant |
MEDICAL ENGINEERING CORP. |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Applicant Contact |
WAXBERG |
Correspondent |
MEDICAL ENGINEERING CORP. |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Correspondent Contact |
WAXBERG |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 04/22/1988 |
Decision Date | 08/11/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|