| Device Classification Name |
Set, Blood Transfusion
|
| 510(k) Number |
K880174 |
| Device Name |
JMS TRANSFUSION SET |
| Applicant |
| Jms Co., Ltd. |
| 12-17, Kako-Machi, Naka-Ku |
|
Hiroshima,
JP
730-8652
|
|
| Applicant Contact |
SAKAE OGATA |
| Correspondent |
| Jms Co., Ltd. |
| 12-17, Kako-Machi, Naka-Ku |
|
Hiroshima,
JP
730-8652
|
|
| Correspondent Contact |
SAKAE OGATA |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 01/15/1988 |
| Decision Date | 02/16/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|