Device Classification Name |
Arterial Blood Sampling Kit
|
510(k) Number |
K897133 |
Device Name |
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT |
Applicant |
TRANSIDYNE GENERAL CORP. |
3711 PLAZA DR., #4 |
ANN ARBOR,
MI
48108
|
|
Applicant Contact |
K BEAUDET |
Correspondent |
TRANSIDYNE GENERAL CORP. |
3711 PLAZA DR., #4 |
ANN ARBOR,
MI
48108
|
|
Correspondent Contact |
K BEAUDET |
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 12/27/1989 |
Decision Date | 03/30/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|