FDA 510(k) Application Details - K003631

Device Classification Name Interferential Current Therapy

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510(K) Number K003631
Device Name Interferential Current Therapy
Applicant NEWWAVE MEDICAL LLC.
620 HAGGARD ST. STE 614
PLANO, TX 75074-5530 US
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Contact ROBERT ARMSTRONG
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Regulation Number 000.0000

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Classification Product Code LIH
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Date Received 11/24/2000
Decision Date 08/10/2001
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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