Device Classification Name |
Plasma, Coagulation Control
|
510(k) Number |
K902362 |
Device Name |
COAGULATION CONTROL, LEVEL II |
Applicant |
SIGMA CHEMICAL CO. |
545 SOUTH EWING AVE. |
ST.LOUIS,
MO
63103
|
|
Applicant Contact |
LAWSON, PHD |
Correspondent |
SIGMA CHEMICAL CO. |
545 SOUTH EWING AVE. |
ST.LOUIS,
MO
63103
|
|
Correspondent Contact |
LAWSON, PHD |
Regulation Number | 864.5425 |
Classification Product Code |
|
Date Received | 05/29/1990 |
Decision Date | 07/26/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|