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 Container, Transport, Kidney
510(k) Number K053169
Device Name RM3 RENAL PRESERVATION SYSTEM
Applicant
WATERS INSTRUMENTS, INC.
2112 15TH ST. N.W., SUITE A
ROCHESTER,  MN  55901
Applicant Contact DAVE SCHOLLMAN
Correspondent
WATERS INSTRUMENTS, INC.
2112 15TH ST. N.W., SUITE A
ROCHESTER,  MN  55901
Correspondent Contact DAVE SCHOLLMAN
Regulation Number876.5880
Classification Product Code
KDK  
Subsequent Product Code
KDN  
Date Received11/14/2005
Decision Date 01/17/2006
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
-
-