Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Number876.5600
Classification Product Code
FKT  
Date Received12/27/2004
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
-
-