FDA 510(k) Application Details - K220040

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K220040
Device Name Device, Neurovascular Embolization
Applicant Medos International, SARL
Chemin-Blanc 38
Le Locle 2400 CH
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Contact Michael Liao
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 01/05/2022
Decision Date 07/14/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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