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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 K170982
Device Name CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
Applicant
Smiths Medical ADS, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Applicant Contact Breanna Fautsch
Correspondent
Smiths Medical ADS, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Correspondent Contact Breanna Fautsch
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Codes
FPA   MRZ   PYR  
Date Received04/03/2017
Decision Date 08/24/2017
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
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