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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 K230083
Device Name SAFIRA
Applicant
Medovate Limited
Camboro Business Park
Girton,  GB CB3 0QH
Applicant Contact Alan Finnerty
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/11/2023
Decision Date 10/31/2023
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
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