Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K081953 |
Device Name |
SUPERCATH 5 |
Applicant |
TOGO MEDIKIT CO., LTD. |
4-2-1 YUSHIMA, BUNKYO-KU |
TOKYO,
JP
113-0034
|
|
Applicant Contact |
FUMIAKI KANAI |
Correspondent |
TOGO MEDIKIT CO., LTD. |
4-2-1 YUSHIMA, BUNKYO-KU |
TOKYO,
JP
113-0034
|
|
Correspondent Contact |
FUMIAKI KANAI |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 07/09/2008 |
Decision Date | 03/12/2009 |
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
|
|
|