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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 K141722
Device Name CAREFUSION GOLD TISSUE MARKER
Applicant
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact JOY GREIDANUS
Correspondent
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact JOY GREIDANUS
Regulation Number878.4300
Classification Product Code
NEU  
Date Received06/25/2014
Decision Date 01/23/2015
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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