Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K982650 |
Device Name |
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) |
Applicant |
DIDECO S.P.A. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
DIDECO S.P.A. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 07/30/1998 |
Decision Date | 12/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|