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FDA 510(k) Application Details - K072534
Device Classification Name
Pad, Heating, Powered
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510(K) Number
K072534
Device Name
Pad, Heating, Powered
Applicant
RICHWAY INTL., INC.
1314 SOUTH KING ST., SUITE 520
HONOLULU, HI 96814 US
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Contact
LEROY KLIMA
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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
09/07/2007
Decision Date
02/08/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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