Device Classification Name |
device, cystometric, hydraulic
|
510(k) Number |
K960503 |
Device Name |
DANTEC DUET |
Applicant |
DANTEC MEDICAL, INC. |
3 PEARL CT. |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
ALAN J SCHAEFER |
Correspondent |
DANTEC MEDICAL, INC. |
3 PEARL CT. |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
ALAN J SCHAEFER |
Regulation Number | 876.1620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/02/1996 |
Decision Date | 09/16/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|