Device Classification Name |
Needle, Fistula
|
510(k) Number |
K854773 |
Device Name |
SUPERCATH A.V. FISTULA |
Applicant |
TOGO MEDIKIT CO., LTD. |
SHOEI-SURVGADAI BLDG |
1-2 KANDA-SURUGADAI 3 CHOME |
CHIYODA-KU TOKYO101 JAPAN,
JP
|
|
Applicant Contact |
HIROAKI NAKAJIMA |
Correspondent |
TOGO MEDIKIT CO., LTD. |
SHOEI-SURVGADAI BLDG |
1-2 KANDA-SURUGADAI 3 CHOME |
CHIYODA-KU TOKYO101 JAPAN,
JP
|
|
Correspondent Contact |
HIROAKI NAKAJIMA |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 11/29/1985 |
Decision Date | 04/08/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|