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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 K180943
Device Name BioWaveGO
Applicant
Biowave Corporation
8 Knight St., Suite 201
Norwalk,  CT  06851
Applicant Contact Bradford Siff
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC (Mcra)
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/10/2018
Decision Date 08/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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