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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K230718
Device Name UTC 3mL Medication Cartridge
Applicant
Gilero, LLC
635 Davis Dr. Suite 100
Morrisville,  NC  27560
Applicant Contact Jessica Czamanski
Correspondent
Gilero, LLC
635 Davis Dr. Suite 100
Morrisville,  NC  27560
Correspondent Contact Jessica Czamanski
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received03/15/2023
Decision Date 06/15/2023
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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