Device Classification Name |
pump, blood, extra-luminal
|
510(k) Number |
K961137 |
Device Name |
ATI PLASMA PUMP (PP-04) |
Applicant |
APHERESIS TECHNOLOGIES, INC. |
612 FLORIDA AVE. |
PALM HARBOR,
FL
34683
|
|
Applicant Contact |
JOHN B CORNISH |
Correspondent |
APHERESIS TECHNOLOGIES, INC. |
612 FLORIDA AVE. |
PALM HARBOR,
FL
34683
|
|
Correspondent Contact |
JOHN B CORNISH |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/21/1996 |
Decision Date | 06/14/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|