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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name percutaneous nerve stimulator for opioid withdrawal
510(k) Number K173861
Device Name Drug Relief
Applicant
DyAnsys, Inc.
300 North Bayshore Boulevard
San Mateo,  CA  94401
Applicant Contact San Mateo
Correspondent
DyAnsys, Inc.
300 North Bayshore Boulevard
San Mateo,  CA  94401
Correspondent Contact San Mateo
Regulation Number882.5896
Classification Product Code
PZR  
Date Received12/20/2017
Decision Date 05/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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