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 K001059
Device Name NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
Applicant
Novex Pharma
380 Elgin Mills Rd. E.
Richmond Hill, Ontario,  CA L4C 5H2
Applicant Contact JOSSEPH W BEYGER
Correspondent
Novex Pharma
380 Elgin Mills Rd. E.
Richmond Hill, Ontario,  CA L4C 5H2
Correspondent Contact JOSSEPH W BEYGER
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/03/2000
Decision Date 06/30/2000
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
-
-