Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K051059 |
Device Name |
AMSURE 100% SILICONE FOLEY CATHETER |
Applicant |
AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DR. |
POMONA,
CA
91767
|
|
Applicant Contact |
CHING CHING SEAH |
Correspondent |
AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DR. |
POMONA,
CA
91767
|
|
Correspondent Contact |
CHING CHING SEAH |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 04/26/2005 |
Decision Date | 06/28/2005 |
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
|
|
|