Device Classification Name |
counter, differential cell
|
510(k) Number |
K961610 |
Device Name |
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) |
Applicant |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Applicant Contact |
KENNETH T EDDS, PH.D. |
Correspondent |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Correspondent Contact |
KENNETH T EDDS, PH.D. |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 04/25/1996 |
Decision Date | 07/01/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|