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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 K081113
Device Name COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
Applicant
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact SUSANNE GALIN
Correspondent
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact SUSANNE GALIN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/18/2008
Decision Date 07/30/2008
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 Yes
Recalls CDRH Recalls
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