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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 K152437
FOIA Releasable 510(k) K152437
Device Name BiowaveHOME Neuromodulation Pain Therapy Device
Applicant
BIOWAVE CORPORATION
16 KNIGHT STREET
NORWALK,  CT  06851
Applicant Contact BRADFORD SIFF
Correspondent
BIOWAVE CORPORATION
16 KNIGHT STREET
NORWALK,  CT  06851
Correspondent Contact BRADFORD SIFF
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/27/2015
Decision Date 09/25/2015
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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