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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K052289
FOIA Releasable 510(k) K052289
Device Name DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
Applicant
Biowave Corporation
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Biowave Corporation
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number882.5890
Classification Product Code
LIH  
Date Received08/23/2005
Decision Date 12/13/2005
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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