FDA 510(k) Application Details - K193374

Device Classification Name Device, Acupressure

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510(K) Number K193374
Device Name Device, Acupressure
Applicant MumEase
227 W 4th Street
Charlotte, NC 28202 US
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Contact Catherine Varley
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Regulation Number 000.0000

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Classification Product Code MVV
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Date Received 12/05/2019
Decision Date 03/04/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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