FDA 510(k) Application Details - K083183

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K083183
Device Name Lamp, Infrared, Therapeutic Heating
Applicant HILL LABORATORIES CO.
3 N. BACTON HILL RD.
FRAZER, PA 19355 US
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Contact BRADY ALLER
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 10/28/2008
Decision Date 07/16/2009
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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