Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K965027 |
Device Name |
VENTED I.V. SET |
Applicant |
JMS CO., LTD. |
12,17,KAKO-MACHI,NAKA-KU |
HIROSHIMA, 730,
JP
|
|
Applicant Contact |
TETSUKARA HIROSE |
Correspondent |
JMS CO., LTD. |
12,17,KAKO-MACHI,NAKA-KU |
HIROSHIMA, 730,
JP
|
|
Correspondent Contact |
TETSUKARA HIROSE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/17/1996 |
Decision Date | 06/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|