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 K151728
Device Name CoStorSol plus G
Applicant
Preservation Solutions, Inc.
1099 Proctor Dr.
Elkhorn,  WI  53121
Applicant Contact GARY SWANSON
Correspondent
Neil Burris & Associates
4250 Grove St.
Denver,  CO  80211
Correspondent Contact NEIL BURRIS
Regulation Number876.5880
Classification Product Code
KDN  
Date Received06/26/2015
Decision Date 09/18/2015
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
-
-