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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, Pca
510(k) Number K130394
Device Name CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
Applicant
SMITHS MEDICAL ASD, INC.
1265 GREY FOX ROAD
ST. PAUL,  MN  55112
Applicant Contact PAULA CORDERO
Correspondent
SMITHS MEDICAL ASD, INC.
1265 GREY FOX ROAD
ST. PAUL,  MN  55112
Correspondent Contact PAULA CORDERO
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Code
MRZ  
Date Received02/15/2013
Decision Date 12/09/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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