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 Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K852955
Device Name HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD
Applicant
Renalchem, Inc.
401 Civic Center Dr.
Suite 620
Santa Ana,  CA  92701
Applicant Contact JOHN ANDERSON
Correspondent
Renalchem, Inc.
401 Civic Center Dr.
Suite 620
Santa Ana,  CA  92701
Correspondent Contact JOHN ANDERSON
Regulation Number876.5820
Classification Product Code
KPO  
Date Received07/11/1985
Decision Date 02/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-