FDA 510(k) Application Details - K173861

Device Classification Name

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510(K) Number K173861
Device Name Drug Relief
Applicant DyAnsys, Inc.
300 North Bayshore Boulevard
San Mateo, CA 94401 US
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Contact San Mateo
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Regulation Number

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Classification Product Code PZR
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Date Received 12/20/2017
Decision Date 05/02/2018
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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