FDA 510(k) Application Details - K963824

Device Classification Name Pad, Heating, Powered

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510(K) Number K963824
Device Name Pad, Heating, Powered
Applicant HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY
402 RINDGE AVE., STE. 17H
CAMBRIDGE, MA 02140 US
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Contact HUAN-CHEN LI
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Regulation Number 890.5740

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Classification Product Code IRT
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Date Received 09/23/1996
Decision Date 12/12/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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