FDA 510(k) Application Details - K091285

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K091285
Device Name Lamp, Infrared, Therapeutic Heating
Applicant AVICENNA LASER TECHNOLOGY, INC.
9822 EAST WASHINGTON ST.
SUITE 6
CHAGRIN FALLS, OH 44023 US
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Contact BRUCE COREN
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 05/01/2009
Decision Date 07/28/2009
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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