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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 K181692
Device Name 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
Applicant
Health Beacons, Inc.
34 Walden St., #753
Concord,  MA  01742
Applicant Contact Nancy Confrey
Correspondent
Regulatory and Quality Solutions, LLC.
2790 Mosside Boulevard, Suite 800
Monroeville,  PA  15146
Correspondent Contact Felicia Hosey
Regulation Number878.4300
Classification Product Code
NEU  
Date Received06/27/2018
Decision Date 09/25/2018
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
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