FDA 510(k) Application Details - K193602

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K193602
Device Name Source, Brachytherapy, Radionuclide
Applicant LV Liberty Vision Corporation
300 West Road, Unit 2
Portsmouth, NH 03874 US
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Contact Paul T. Finger
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 12/23/2019
Decision Date 05/29/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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