Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K821216 |
Device Name |
INTERPULSE MEMBRANE OXYGENATOR |
Applicant |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 04/27/1982 |
Decision Date | 06/02/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|