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 K133694
Device Name SHERPA PAK TRANSPORTER
Applicant
PARAGONIX TECHNOLOGIES, INC.
93 BENEFIT STREET
PROVIDENCE,  RI  02904
Applicant Contact LEO BASTA
Correspondent
PARAGONIX TECHNOLOGIES, INC.
93 BENEFIT STREET
PROVIDENCE,  RI  02904
Correspondent Contact LEO BASTA
Regulation Number876.5880
Classification Product Code
KDN  
Date Received12/03/2013
Decision Date 05/23/2014
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
-
-