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FDA 510(k) Application Details - K032231
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K032231
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
MEDX ELECTRONICS, INC.
3535 LAIRD ROAD
UNIT 2
MISSISSAUGA L5L 5Y7 CA
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Contact
ANITA SALTMARCHE
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Regulation Number
890.5500
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Classification Product Code
ILY
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Date Received
07/21/2003
Decision Date
10/03/2003
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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