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FDA 510(k) Application Details - K150716
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K150716
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
VARAYA PHOTOCEUTICALS, LLC
16511 SCIENTIFIC WAY
SUITE 200
IRVINE, CA 92618 US
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Contact
Myk Lum
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
03/19/2015
Decision Date
12/08/2015
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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