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FDA 510(k) Application Details - K123474
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K123474
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
AVANT WELLNESS SYSTEMS, LLC
1020 CALLE CORDILLERA, STE 107
SAN CLEMENTE, CA 92673 US
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Contact
ANDY HEWITSON
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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
11/13/2012
Decision Date
12/03/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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