Device Classification Name |
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
|
510(k) Number |
K913323 |
Device Name |
ETUDE (MODEL NUMBERS 24A05 & 24A06) |
Applicant |
DANTEC MEDICAL, INC. |
1575 EYE STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
RICHARD D MANTHEI |
Correspondent |
DANTEC MEDICAL, INC. |
1575 EYE STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
RICHARD D MANTHEI |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 07/25/1991 |
Decision Date | 09/23/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|