Device Classification Name |
device, cystometric, hydraulic
|
510(k) Number |
K913721 |
Device Name |
FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM |
Applicant |
FIBEROPTIC SENSOR TECHNLOGIES, INC. |
501 AVIS DR. |
ANN ARBOR,
MI
48108
|
|
Applicant Contact |
DOUGLAS G TOMASKO |
Correspondent |
FIBEROPTIC SENSOR TECHNLOGIES, INC. |
501 AVIS DR. |
ANN ARBOR,
MI
48108
|
|
Correspondent Contact |
DOUGLAS G TOMASKO |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 08/20/1991 |
Decision Date | 10/08/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|