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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K213429
Device Name AccuSert Needle Inserter
Applicant
Emed Technologies Corporation
1262 Hawks Flight Ct.
Suite 200
El Dorado Hills,  CA  95762
Applicant Contact Peter Kollings
Correspondent
Emed Technologies Corporation
1262 Hawks Flight Ct.
Suite 200
El Dorado Hills,  CA  95762
Correspondent Contact Olena Whalen
Regulation Number880.6920
Classification Product Code
KZH  
Date Received10/21/2021
Decision Date 10/20/2022
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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