Device Classification Name |
needle, fistula
|
510(k) Number |
K000845 |
Device Name |
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET |
Applicant |
JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU |
HIROSHIMA,
JP
730-8652
|
|
Applicant Contact |
KEISUKE URATOMI |
Correspondent |
JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU |
HIROSHIMA,
JP
730-8652
|
|
Correspondent Contact |
KEISUKE URATOMI |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 03/15/2000 |
Decision Date | 04/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|