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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 K072144
Device Name CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Applicant Contact PHIL NEURURER
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Correspondent Contact PHIL NEURURER
Regulation Number880.5725
Classification Product Code
MEA  
Date Received08/02/2007
Decision Date 03/07/2008
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 No
Recalls CDRH Recalls
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