FDA 510(k) Application Details - K024179

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K024179
Device Name Lamp, Infrared, Therapeutic Heating
Applicant PALOMAR MEDICAL PRODUCTS, INC.
131 KELEKENT LN.
CARY, NC 27511 US
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Contact Marcy Moore
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/18/2002
Decision Date 06/04/2003
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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