Device Classification Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
|
510(k) Number |
K833322 |
Device Name |
TUBING CONNECTORS EC-2XXX SERIES |
Applicant |
GISH BIOMEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GISH BIOMEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 09/26/1983 |
Decision Date | 12/16/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|