Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K160197 |
Device Name |
Haemonetics Cell Saver Elite Autotransfusion System |
Applicant |
Haemonetics Corporation |
400 WOOD ROAD |
BRAINTREE,
MA
02184
|
|
Applicant Contact |
Mark Anzalone |
Correspondent |
Haemonetics Corporation |
400 WOOD ROAD |
BRAINTREE,
MA
02184
|
|
Correspondent Contact |
Mark Anzalone |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 01/27/2016 |
Decision Date | 05/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|