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 System, Perfusion, Kidney
510(k) Number K971571
Device Name RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
Applicant
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903 -6117
Applicant Contact DAVE SCHOLLMAN
Correspondent
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903 -6117
Correspondent Contact DAVE SCHOLLMAN
Regulation Number876.5880
Classification Product Code
KDN  
Date Received04/30/1997
Decision Date 07/29/1997
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
-
-