Anjon Bremer Halo System

Component, Traction, Invasive

Anjon Holdings, LLC

The following data is part of a premarket notification filed by Anjon Holdings, Llc with the FDA for Anjon Bremer Halo System.

Pre-market Notification Details

Device IDK171863
510k NumberK171863
Device Name:Anjon Bremer Halo System
ClassificationComponent, Traction, Invasive
Applicant Anjon Holdings, LLC 4801 Dawin Rd Jacksonville,  FL  32207
ContactTommy Mitchell
CorrespondentJohn Kapitan
Kapstone Medical P.O. Box 969 Leicester,  NC  28748
Product CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-22
Decision Date2018-03-19
Summary:summary

NIH GUDID Devices

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