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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Tissue Marker
510(k) Number K163667
Device Name RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
Applicant
Health Beacons, Inc.
34 Walden St. #753
Concord,  MA  01742
Applicant Contact NANCY CONFREY
Correspondent
Health Beacons, Inc.
34 Walden St. #753
Concord,  MA  01742
Correspondent Contact NANCY CONFREY
Regulation Number878.4300
Classification Product Code
PBY  
Date Received12/27/2016
Decision Date 04/28/2017
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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