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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 K173783
Device Name SCIg60 Infusion System
Applicant
Emed Technologies Corporation
1264 Hawks Flight Ct, Suite 200
El Dorado Hills,  CA  95762
Applicant Contact Peter Kollings
Correspondent
Emed Technologies Corporation
1264 Hawks Flight Ct, Suite 200
El Dorado Hills,  CA  95762
Correspondent Contact Peter Kollings
Regulation Number880.5725
Classification Product Code
PKP  
Date Received12/13/2017
Decision Date 12/14/2018
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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