Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K874759 |
Device Name |
13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE |
Applicant |
DANTEC ELECTRONICS, INC. |
6 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
HENRIK HENRIKSEN |
Correspondent |
DANTEC ELECTRONICS, INC. |
6 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
HENRIK HENRIKSEN |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 11/18/1987 |
Decision Date | 04/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|