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FDA 510(k) Application Details - K024361
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K024361
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
EM PROBE INC.
1501 OLD GARDINER RD.
SEQUIM, WA 98382 US
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Contact
GLEN A GORDON
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Regulation Number
890.5500
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Classification Product Code
ILY
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More FDA Info for this Product Code
Date Received
12/30/2002
Decision Date
10/09/2003
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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