Device Classification Name |
tray, catheterization, sterile urethral, with or without catheter (kit)
|
510(k) Number |
K030664 |
Device Name |
AMSURE FOLEY INSERTION TRAY |
Applicant |
AMSINO INTERNATIONAL, INC. |
4501 BRICKELL PRIVADO ST. |
ONTARIO,
CA
91761
|
|
Applicant Contact |
CHING CHING SEAH |
Correspondent |
AMSINO INTERNATIONAL, INC. |
4501 BRICKELL PRIVADO ST. |
ONTARIO,
CA
91761
|
|
Correspondent Contact |
CHING CHING SEAH |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 03/03/2003 |
Decision Date | 05/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|