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 Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K992894
Device Name MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact ROBERT L WILKINSON
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/27/1999
Decision Date 11/24/1999
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
Recalls CDRH Recalls
-
-