Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K993581 |
Device Name |
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER |
Applicant |
HAEMONETICS CORP. |
400 WOOD RD. |
P.O. BOX 9114 |
BRAINTREE,
MA
02184
|
|
Applicant Contact |
ALICIA R LOPEZ |
Correspondent |
HAEMONETICS CORP. |
400 WOOD RD. |
P.O. BOX 9114 |
BRAINTREE,
MA
02184
|
|
Correspondent Contact |
ALICIA R LOPEZ |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 10/22/1999 |
Decision Date | 11/18/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|