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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K210202
Device Name BioWaveGO RX
Applicant
BioWave Corporation
8 Knight Street, Suite 201
Norwalk,  CT  06851
Applicant Contact Bradford Siff
Correspondent
MCRA LLC
1050 K Street NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/25/2021
Decision Date 02/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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