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 K041683
Device Name B. BRAUN BICARBONATE DIALYSATE
Applicant
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Applicant Contact JENNIFER A PUNG
Correspondent
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Correspondent Contact JENNIFER A PUNG
Regulation Number876.5820
Classification Product Code
KPO  
Date Received06/21/2004
Decision Date 08/27/2004
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
-
-