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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 K010034
Device Name DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
Applicant
COOK, INC.
925 SOUTH CURRY PK
BLOOMINGTON,  IN  47403 -2624
Applicant Contact LISA WEBB
Correspondent
COOK, INC.
925 SOUTH CURRY PK
BLOOMINGTON,  IN  47403 -2624
Correspondent Contact LISA WEBB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/04/2001
Decision Date 01/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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