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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, long-term greater than 30 days
510(k) Number K072625
Device Name TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
bloomington,  IN  47402
Applicant Contact karen bradburn
Correspondent
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
bloomington,  IN  47402
Correspondent Contact karen bradburn
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/17/2007
Decision Date 12/13/2007
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
Recalls CDRH Recalls
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