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FDA 510(k) Application Details - K153399
Device Classification Name
Lamp, Infrared, Therapeutic Heating
More FDA Info for this Device
510(K) Number
K153399
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
LED Intellectual Properties LLC
16552 Von Karman Ave
Irvine, CA 92606 US
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Contact
Steve Marchese
Other 510(k) Applications for this Contact
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
11/24/2015
Decision Date
07/05/2016
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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