Device Classification Name |
adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
|
510(k) Number |
K870325 |
Device Name |
#014160-TAB TUBING ROTATOR ADAPTOR |
Applicant |
CLINICAL CONNECTIONS, INC. |
P.O. BOX 238 |
9287 SMUCKER ROAD |
ORRVILLE,
OH
44667
|
|
Applicant Contact |
KEITH ANTAL |
Correspondent |
CLINICAL CONNECTIONS, INC. |
P.O. BOX 238 |
9287 SMUCKER ROAD |
ORRVILLE,
OH
44667
|
|
Correspondent Contact |
KEITH ANTAL |
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 01/28/1987 |
Decision Date | 04/27/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|