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 K042938
FOIA Releasable 510(k) K042938
Device Name GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
Applicant
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact THOMAS B DOWELL
Correspondent
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact THOMAS B DOWELL
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/25/2004
Decision Date 01/06/2005
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
Recalls CDRH Recalls
-
-