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 K150966
Device Name HMB32
Applicant
Haemopharm Biofluids S.R.L.
Via Dell'Industria 6
Tovo Di S. Agata,  IT 23030
Applicant Contact GIUSEPPE TOMASINI
Correspondent
Heyer Regulatory Solutions, LLC
P.O. Box 2151
Amherst,  MA  01004
Correspondent Contact SHELIA HEMEON-HEYER
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/13/2015
Decision Date 12/04/2015
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
-
-