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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 K240429
Device Name Trilogy Tissue Marker
Applicant
Inrad, Inc.
4375 Donker Court SE
Kentwood,  MI  49512
Applicant Contact Heidi Halverson
Correspondent
Inrad, Inc.
4375 Donker Court SE
Kentwood,  MI  49512
Correspondent Contact Heidi Halverson
Regulation Number878.4300
Classification Product Code
NEU  
Date Received02/13/2024
Decision Date 11/07/2024
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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