Device Classification Name |
Reservoir, Blood, Cardiopulmonary Bypass
|
510(k) Number |
K051606 |
Device Name |
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING |
Applicant |
GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE |
HOUSTON,
TX
77071
|
|
Applicant Contact |
J. HARVEY KNAUSS |
Correspondent |
GISH BIOMEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE |
HOUSTON,
TX
77071
|
|
Correspondent Contact |
J. HARVEY KNAUSS |
Regulation Number | 870.4400
|
Classification Product Code |
|
Date Received | 06/16/2005 |
Decision Date | 08/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|