Device Classification Name |
clamp, umbilical
|
510(k) Number |
K033846 |
Device Name |
KAEN YIH UMBILICAL CORD CLAMP |
Applicant |
KAEN YIH ENTERPRISE CO., LTD. |
1202 S. RTE. 31 |
MCHENRY,
IL
60050
|
|
Applicant Contact |
ANTONIO L GIACCIO |
Correspondent |
KAEN YIH ENTERPRISE CO., LTD. |
1202 S. RTE. 31 |
MCHENRY,
IL
60050
|
|
Correspondent Contact |
ANTONIO L GIACCIO |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 12/11/2003 |
Decision Date | 03/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|