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 Set, Perfusion, Kidney, Disposable
510(k) Number K091656
Device Name SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
Applicant
Organ Recovery Systems, Inc.
2570 E. Devon Ave.
Des Plaines,  IL  60018 -4912
Applicant Contact PJ PARDO
Correspondent
Organ Recovery Systems, Inc.
2570 E. Devon Ave.
Des Plaines,  IL  60018 -4912
Correspondent Contact PJ PARDO
Regulation Number876.5880
Classification Product Code
KDL  
Date Received06/09/2009
Decision Date 03/11/2010
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
Recalls CDRH Recalls
-
-