Device Classification Name |
system, perfusion, kidney
|
510(k) Number |
K080432 |
Device Name |
MAPERSOL |
Applicant |
PRESERVATION SOLUTIONS, INC. |
4250 GROVE STREET |
DENVER,
CO
80211
|
|
Applicant Contact |
NEIL BURRIS |
Correspondent |
PRESERVATION SOLUTIONS, INC. |
4250 GROVE STREET |
DENVER,
CO
80211
|
|
Correspondent Contact |
NEIL BURRIS |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 02/19/2008 |
Decision Date | 08/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|