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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K183503
Device Name EasyMark Tissue Marker
Applicant
Inrad, Inc.
4375 Donker Court SE
Kentwood,  MI  49512
Applicant Contact Steve Field
Correspondent
Inrad, Inc.
4375 Donker Court SE
Kentwood,  MI  49512
Correspondent Contact Steve Field
Regulation Number878.4300
Classification Product Code
NEU  
Date Received12/17/2018
Decision Date 10/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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