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FDA 510(k) Application Details - K090008
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K090008
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
PHAROS LIFE CORPORATION
11-380 JAMIESON PKWY
CAMBRIDGE, ONTARIO N3C 4N4 CA
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PHIL CUSCUNA
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Regulation Number
890.5500
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Classification Product Code
ILY
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Date Received
01/02/2009
Decision Date
10/15/2009
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
Y
Expedited Review
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