Device Classification Name |
Needle, Fistula
|
510(k) Number |
K990470 |
FOIA Releasable 510(k) |
K990470
|
Device Name |
JMS A. V. FISTULA NEEDLE SET |
Applicant |
JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU |
HIROSHIMA,
JP
730-8652
|
|
Applicant Contact |
TETSUHARU HIROSE |
Correspondent |
JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU |
HIROSHIMA,
JP
730-8652
|
|
Correspondent Contact |
TETSUHARU HIROSE |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 02/16/1999 |
Decision Date | 08/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|