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510(k) K203250

TaiChiC by Our United Corporation — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2021
Date Received
November 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Radionuclide
Device Class
Class II
Regulation Number
892.5750
Review Panel
RA
Submission Type

Other clearances by Our United Corporation

  • K210921 — TaiChiB (November 2, 2021)
  • K193207 — TaiChiA (August 7, 2020)

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