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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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More FDA Info for this Product Code
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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