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FDA 510(k) Application Details - K150175
Device Classification Name
Lamp, Infrared, Therapeutic Heating
More FDA Info for this Device
510(K) Number
K150175
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
HOME SKINOVATIONS LTD.
Tabor Building, Shaar Yokneam
Yoqneam Iillit 2069200 IL
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Contact
Ahava Stein
Other 510(k) Applications for this Contact
Regulation Number
890.5500
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Classification Product Code
ILY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/26/2015
Decision Date
03/31/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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