Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K030264 |
Device Name |
QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 |
Applicant |
JOSTRA AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Applicant Contact |
KATRIN SCHWENKGLENKS |
Correspondent |
JOSTRA AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Correspondent Contact |
KATRIN SCHWENKGLENKS |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 01/27/2003 |
Decision Date | 02/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|