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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, electrical, percutaneous (pens), for pain relief
510(k) Number K061166
Device Name DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
Applicant
BIOWAVE CORPORATION
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
BIOWAVE CORPORATION
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number882.5890
Classification Product Code
NHI  
Subsequent Product Code
GZJ  
Date Received04/27/2006
Decision Date 08/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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