FDA 510(k) Application Details - K052289

Device Classification Name Interferential Current Therapy

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510(K) Number K052289
Device Name Interferential Current Therapy
Applicant BIOWAVE CORPORATION
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 000.0000

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Classification Product Code LIH
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Date Received 08/23/2005
Decision Date 12/13/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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