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FDA 510(k) Application Details - K120254
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K120254
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
THERASAGE CORPORATION
21000 Boca Rio Road,
Suite A21-C
BOCA RATON, FL 33433 US
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Contact
ROBERT BESNER
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Regulation Number
890.5500
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Classification Product Code
ILY
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Date Received
01/27/2012
Decision Date
03/06/2012
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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