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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 St., Suite 201
Norwalk,  CT  06851
Applicant Contact Bradford Siff
Correspondent
MCRA, LLC
1050 K. St. 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
Predetermined Change
Control Plan Authorized		 No
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