Device Classification Name |
set, perfusion, kidney, disposable
|
510(k) Number |
K121618 |
Device Name |
BEL-GEN COLD STORAGE SOLUTION |
Applicant |
WATERS MEDICAL SYSTEMS, LLC |
2112 15TH ST. N.W. |
ROCHESTER,
MN
55901
|
|
Applicant Contact |
ROBERT WARREN |
Correspondent |
WATERS MEDICAL SYSTEMS, LLC |
2112 15TH ST. N.W. |
ROCHESTER,
MN
55901
|
|
Correspondent Contact |
ROBERT WARREN |
Regulation Number | 876.5880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 06/14/2013 |
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
|
|
|