• 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 K982760
Device Name COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
Applicant
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Applicant Contact WILLIAM M TOWNSEND
Correspondent
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Correspondent Contact WILLIAM M TOWNSEND
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/06/1998
Decision Date 11/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-