Device Classification Name |
device, cystometric, hydraulic
|
510(k) Number |
K970595 |
Device Name |
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP |
Applicant |
CIRCON VIDEO |
6500 HOLLISTER AVE. |
SANTA BARBARA,
CA
93117 -3019
|
|
Applicant Contact |
TODD J POLK |
Correspondent |
CIRCON VIDEO |
6500 HOLLISTER AVE. |
SANTA BARBARA,
CA
93117 -3019
|
|
Correspondent Contact |
TODD J POLK |
Regulation Number | 876.1620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/18/1997 |
Decision Date | 10/24/1997 |
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
|
|
|