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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K070268
Device Name SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
Applicant
CARDINAL HEALTH 303, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Applicant Contact STACY L LEWIS
Correspondent
CARDINAL HEALTH 303, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Correspondent Contact STACY L LEWIS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/29/2007
Decision Date 02/23/2007
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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