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 K863631
Device Name SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
Applicant
American Healthcare Corp.
825 Hillside Ct.
Longmont,  CO  80501
Applicant Contact JIM WELSCH
Correspondent
American Healthcare Corp.
825 Hillside Ct.
Longmont,  CO  80501
Correspondent Contact JIM WELSCH
Regulation Number876.5820
Classification Product Code
KPO  
Date Received09/17/1986
Decision Date 10/16/1986
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
-
-