Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K024007 |
Device Name |
SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J |
Applicant |
SUNDER BIOMEDICAL TECH. CO., LTD. |
10F-1, 1-67, WU-CHUAN RD. |
TAICHUNG CITY,
TW
403
|
|
Applicant Contact |
TONY HUNG |
Correspondent |
SUNDER BIOMEDICAL TECH. CO., LTD. |
10F-1, 1-67, WU-CHUAN RD. |
TAICHUNG CITY,
TW
403
|
|
Correspondent Contact |
TONY HUNG |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/04/2002 |
Decision Date | 07/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|