Device Classification Name |
Microfilter, Blood Transfusion
|
510(k) Number |
K830014 |
Device Name |
HEMA - NV TRANS. BLOOD FILTER 100/800 |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/03/1983 |
Decision Date | 01/17/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|