Device Classification Name |
System, Dialysate Delivery, Sorbent Regenerated
|
510(k) Number |
K123835 |
Device Name |
2008 HEMODIALYSIS SORBENT SYSTEM |
Applicant |
RENAL SOLUTIONS, INC. |
770 COMMONWEALTH DR. |
WARRENDALE,
PA
15086
|
|
Applicant Contact |
DAVID VANELLA |
Correspondent |
RENAL SOLUTIONS, INC. |
770 COMMONWEALTH DR. |
WARRENDALE,
PA
15086
|
|
Correspondent Contact |
DAVID VANELLA |
Regulation Number | 876.5600
|
Classification Product Code |
|
Date Received | 12/13/2012 |
Decision Date | 02/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|