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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K201936
Device Name SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
Applicant
Gilero, LLC
635 Davis Dr. Suite 100
Morrisville,  NC  27560
Applicant Contact Kristin Benokraitis
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.5025
Classification Product Code
KPE  
Date Received07/13/2020
Decision Date 05/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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