Device Classification Name |
System, Dialysate Delivery, Sorbent Regenerated
|
510(k) Number |
K043574 |
Device Name |
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 |
Applicant |
RENAL SOLUTIONS, INC. |
700 COMMONWEALTH DR SUITE 101 |
WARRENDALE,
PA
15086
|
|
Applicant Contact |
RICHARD CONFER |
Correspondent |
RENAL SOLUTIONS, INC. |
700 COMMONWEALTH DR SUITE 101 |
WARRENDALE,
PA
15086
|
|
Correspondent Contact |
RICHARD CONFER |
Regulation Number | 876.5600
|
Classification Product Code |
|
Date Received | 12/27/2004 |
Decision Date | 06/03/2005 |
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
|
|
|