FDA 510(k) Application Details - K043317

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K043317
Device Name Lamp, Infrared, Therapeutic Heating
Applicant PHOTO THERAPEUTICS LIMITED
STATION HOUSE
STAMFORD NEW ROAD
ALTRINCHAM, CHESHIRE WA14 1EP GB
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Contact STEVEN G HUTSON
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/02/2004
Decision Date 03/15/2005
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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