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FDA 510(k) Application Details - K151521
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K151521
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
PHOENIX THERA-LASE SYSTEMS, LLC
5454 LA SIERRA DRIVE, SUITE 203
DALLAS, TX 75231 US
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Contact
GARY BELLINGER
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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
06/05/2015
Decision Date
09/04/2015
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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