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 K162887
Device Name PrismaSATE
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Rd.
Round Lake,  IL  60073
Applicant Contact Kristen Bozzelli
Correspondent
Baxter Healthcare Corporation
32650 N. Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact Kristen Bozzelli
Regulation Number876.5820
Classification Product Code
KPO  
Date Received10/17/2016
Decision Date 01/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-