Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K131553 |
Device Name |
XTRA |
Applicant |
SORIN GROUP DEUTSCHLAND GMBH |
195 WEST STREET |
WALTHAM,
MA
02451
|
|
Applicant Contact |
BARRY SALL, RAC, FRAPS |
Correspondent |
SORIN GROUP DEUTSCHLAND GMBH |
195 WEST STREET |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
BARRY SALL, RAC, FRAPS |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 05/30/2013 |
Decision Date | 03/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|