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510(k) K243045

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) by Braxx Biotech Co., Ltd. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2024
Date Received
September 27, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

Other clearances by Braxx Biotech Co., Ltd.

  • K183332 — “BRAXX” Esophageal Brachytherapy Applicator (April 16, 2019)

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