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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 K100974
Device Name SPECTRUM TURBO-JECT PICC SET
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact SUSANNE GALIN
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact SUSANNE GALIN
Regulation Number880.5200
Classification Product Code
FOZ  
Subsequent Product Code
LJS  
Date Received04/08/2010
Decision Date 05/06/2010
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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