Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K014083 |
Device Name |
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM |
Applicant |
HAEMONETICS CORP. |
400 WOOD RD. |
P.O. BOX 9114 |
BRAINTREE,
MA
02184
|
|
Applicant Contact |
JOHN SOKOLOWSKI |
Correspondent |
HAEMONETICS CORP. |
400 WOOD RD. |
P.O. BOX 9114 |
BRAINTREE,
MA
02184
|
|
Correspondent Contact |
JOHN SOKOLOWSKI |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 12/11/2001 |
Decision Date | 01/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|