Device Classification Name |
Device, Cystometric, Hydraulic
|
510(k) Number |
K922776 |
Device Name |
FST COUNCIL TIP FOLEY CATHETER |
Applicant |
FIBEROPTIC SENSOR TECHNLOGIES, INC. |
501 AVIS DR. |
ANN ARBOR,
MI
48108
|
|
Applicant Contact |
MICHAEL D COLLIVER |
Correspondent |
FIBEROPTIC SENSOR TECHNLOGIES, INC. |
501 AVIS DR. |
ANN ARBOR,
MI
48108
|
|
Correspondent Contact |
MICHAEL D COLLIVER |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 06/09/1992 |
Decision Date | 07/20/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|