FDA 510(k) Application Details - K221231

Device Classification Name

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510(K) Number K221231
Device Name Drug Relief v1
Applicant DyAnsys, Inc.
300, North Bayshore Boulevard
San Mateo, CA 94401 US
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Contact Srini Nageshwar
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Regulation Number

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Classification Product Code PZR
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Date Received 04/29/2022
Decision Date 06/06/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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