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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoglobulin G (Igg) Infusion System
510(k) Number K222087
Device Name SCIg60 Infusion System
Applicant
EMED Technologies Corporation
1262 Hawks Flight Court
Suite 200
El Dorado Hills,  CA  95762
Applicant Contact Olena Whalen
Correspondent
EMED Technologies Corporation
1262 Hawks Flight Court
Suite 200
El Dorado Hills,  CA  95762
Correspondent Contact Olena Whalen
Regulation Number880.5725
Classification Product Code
PKP  
Date Received07/15/2022
Decision Date 10/13/2022
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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