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FDA 510(k) Application Details - K223642
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K223642
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague NL
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Contact
Alain Dijkstra
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
12/06/2022
Decision Date
03/09/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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