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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K171863
Device Name Anjon Bremer Halo System
Applicant
Anjon Holdings, LLC
4801 Dawin Rd
Jacksonville,  FL  32207
Applicant Contact Tommy Mitchell
Correspondent
Kapstone Medical
P.O. Box 969
Leicester,  NC  28748
Correspondent Contact John Kapitan
Regulation Number888.3040
Classification Product Code
JEC  
Date Received06/22/2017
Decision Date 03/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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