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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 K193256
Device Name Anjon Bremer Halo System
Applicant
Anjon Holdings LLC
4801 Dawin Road
Jacksonville,  FL  32207
Applicant Contact Kenneth A Collins
Correspondent
Anjon Holdings LLC
4801 Dawin Road
Jacksonville,  FL  32207
Correspondent Contact Kenneth A Collins
Regulation Number888.3040
Classification Product Code
JEC  
Date Received11/26/2019
Decision Date 03/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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