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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 K141818
Device Name TURBO-JECT PICC SETS
Applicant
Cook Corporated
60 Daniels Way
Bloomington,  IN  47404
Applicant Contact SEAN SPENE
Correspondent
Cook Corporated
60 Daniels Way
Bloomington,  IN  47404
Correspondent Contact SEAN SPENE
Regulation Number880.5970
Classification Product Code
LJS  
Date Received07/07/2014
Decision Date 08/05/2014
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 No
Predetermined Change
Control Plan Authorized		 No
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