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 K896111
Device Name FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
Applicant
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Applicant Contact BRUCE CROOK
Correspondent
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Correspondent Contact BRUCE CROOK
Regulation Number876.5820
Classification Product Code
KPO  
Date Received10/23/1989
Decision Date 12/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-