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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 K193189
Device Name RFID Localization System
Applicant
Health Beacons, Inc.
34 Walden St. #753
Concord,  MA  01742
Applicant Contact Nancy Confrey
Correspondent
R&Q Solutions
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Felicia Hosey
Regulation Number878.4300
Classification Product Code
NEU  
Date Received11/19/2019
Decision Date 05/06/2020
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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