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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 K211971
Device Name Drug Relief v1
Applicant
DyAnsys, Inc.
300, North Bayshore Boulevard
San Mateo,  CA  94401
Applicant Contact Srini Nageshwar
Correspondent
DyAnsys, Inc.
300, North Bayshore Boulevard
San Mateo,  CA  94401
Correspondent Contact Srini Nageshwar
Regulation Number882.5896
Classification Product Code
PZR  
Date Received06/24/2021
Decision Date 11/05/2021
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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