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 Pump, Infusion
510(k) Number K910007
Device Name SPRINGFUSOR 10R
Applicant
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Applicant Contact DAVID CAPES
Correspondent
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Correspondent Contact DAVID CAPES
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/02/1991
Decision Date 11/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-