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FDA 510(k) Application Details - K082686
Device Classification Name
Lamp, Infrared, Therapeutic Heating
More FDA Info for this Device
510(K) Number
K082686
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
UNITED INTEGRATED SERVICES CO., LTD.
3 F., NO. 4, LANE 7
PAOKAO ROAD
HSINTIEN CITY, TAIPEI HSIEN 23114 TW
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Contact
DAVID O CHANG
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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
09/15/2008
Decision Date
05/11/2009
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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