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FDA 510(k) Application Details - K160849
Device Classification Name
Lamp, Infrared, Therapeutic Heating
More FDA Info for this Device
510(K) Number
K160849
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
2F, NO.4, LANE 130, MINQUAN RD.
XINDIAN DIST.
New Taipei City 231 TW
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Contact
CHIH-WEN TSAI
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
03/28/2016
Decision Date
12/15/2016
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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