Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K896575 |
Device Name |
DANTEC MENUET |
Applicant |
DANTEC MEDICAL, INC. |
777 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
JAMES T QUIGLEY |
Correspondent |
DANTEC MEDICAL, INC. |
777 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
JAMES T QUIGLEY |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 11/20/1989 |
Decision Date | 05/03/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|