Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K122262 |
Device Name |
ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM |
Applicant |
HAEMONETICS CORP. |
4925 Robert J Mathews Pkwy Ste 100 |
EL DORADO HILLS,
CA
95762
|
|
Applicant Contact |
ERICA DIAZ |
Correspondent |
HAEMONETICS CORP. |
4925 Robert J Mathews Pkwy Ste 100 |
EL DORADO HILLS,
CA
95762
|
|
Correspondent Contact |
ERICA DIAZ |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 10/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|