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 K042172
FOIA Releasable 510(k) K042172
Device Name CLEO 90 INFUSION SET
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX ROAD
ST. PAUL,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX ROAD
ST. PAUL,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/11/2004
Decision Date 10/07/2004
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
-
-