| Device Classification Name |
Microfilter, Blood Transfusion
|
| 510(k) Number |
K810855 |
| Device Name |
INTERFACE 20 MICRON TRANSFUSION BLD. F. |
| Applicant |
| Abbott Laboratories |
| One Abbott Park Rd. |
|
Abbott Park,
IL
60064
|
|
| Correspondent |
| Abbott Laboratories |
| One Abbott Park Rd. |
|
Abbott Park,
IL
60064
|
|
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 03/30/1981 |
| Decision Date | 04/21/1981 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
Hematology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|