Device Classification Name |
reservoir, blood, cardiopulmonary bypass
|
510(k) Number |
K140321 |
Device Name |
INITARY BETTER BLADDER-PEDIATRIC |
Applicant |
CIRCULATORY TECHNOLOGY, INC. |
21 SINGWORTH ST. |
OYSTER BAY,
NY
11771
|
|
Applicant Contact |
YEHUDA TAMARI |
Correspondent |
CIRCULATORY TECHNOLOGY, INC. |
21 SINGWORTH ST. |
OYSTER BAY,
NY
11771
|
|
Correspondent Contact |
YEHUDA TAMARI |
Regulation Number | 870.4400
|
Classification Product Code |
|
Date Received | 02/18/2014 |
Decision Date | 04/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|