FDA 510(k) Application Details - K100246

Device Classification Name Interferential Current Therapy

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510(K) Number K100246
Device Name Interferential Current Therapy
Applicant BIO PROTECH, INC.
3010 LBJ FRWY.
12TH FLOOR
DALLAS, TX 75234 US
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Contact JUDY BURTON
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Regulation Number 000.0000

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Classification Product Code LIH
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Date Received 01/27/2010
Decision Date 11/24/2010
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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