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510(k) K193256

Anjon Bremer Halo System by Anjon Holdings, LLC — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2020
Date Received
November 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Anjon Holdings, LLC

  • K171863 — Anjon Bremer Halo System (March 19, 2018)

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