• 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 catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K060174
Device Name SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
Applicant
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact EVANGELINE D LOH
Correspondent
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact EVANGELINE D LOH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/23/2006
Decision Date 02/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
-
-