FDA 510(k) Application Details - K142256

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K142256
Device Name Lamp, Infrared, Therapeutic Heating
Applicant APPLIED BIOPHOTONICS LTD.
15TH FLOOR, FAR EAST CONSORTIUM BUILDING 121 DES VOEUX RD
CENTRAL CN
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Contact ERIC HSIEH
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 08/14/2014
Decision Date 01/07/2015
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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