Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K912609 |
Device Name |
MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950 |
Applicant |
ATRIUM MEDICAL CORP. |
17 CLINTON DR. |
HOLLIS,
NH
03049
|
|
Applicant Contact |
TED KARWOSKI |
Correspondent |
ATRIUM MEDICAL CORP. |
17 CLINTON DR. |
HOLLIS,
NH
03049
|
|
Correspondent Contact |
TED KARWOSKI |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 06/12/1991 |
Decision Date | 11/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|