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, Administration, Intravascular
510(k) Number K033892
Device Name ULTRAFLEX INFUSION SET
Applicant
DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERSTRASSE 190, POSTFACH
BURGDORF,  SE CH-3401
Applicant Contact BERND HENNINGSEN
Correspondent
DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERSTRASSE 190, POSTFACH
BURGDORF,  SE CH-3401
Correspondent Contact BERND HENNINGSEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/16/2003
Decision Date 03/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-