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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Predetermined Change
Control Plan Authorized		 No
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