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 Subsystem, Water Purification
510(k) Number K061782
Device Name GAMBRO POSICLEAR
Applicant
Gambro Services, Inc.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Applicant Contact JEFFERY R SHIDEMAN
Correspondent
Gambro Services, Inc.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Correspondent Contact JEFFERY R SHIDEMAN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/26/2006
Decision Date 01/04/2007
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
-
-