Device Classification Name |
Container, Empty, For Collection & Processing Of Blood & Blood Components
|
510(k) Number |
K810313 |
Device Name |
HAEMONETICS 1400 ML THERAPEUTIC BAG |
Applicant |
HAEMONETICS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HAEMONETICS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 864.9100
|
Classification Product Code |
|
Date Received | 02/05/1981 |
Decision Date | 03/31/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|