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 Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
510(k) Number K090338
Device Name ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
Applicant
Reprocessing Products Corp
8662 Comstock Ln.
Maple Grove,  MN  55311
Applicant Contact WALLY JANSEN
Correspondent
Reprocessing Products Corp
8662 Comstock Ln.
Maple Grove,  MN  55311
Correspondent Contact WALLY JANSEN
Regulation Number876.5665
Classification Product Code
MSY  
Date Received02/10/2009
Decision Date 05/08/2009
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
Predetermined Change
Control Plan Authorized		 No
-
-