FDA 510(k) Application Details - K102375

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K102375
Device Name Lamp, Infrared, Therapeutic Heating
Applicant MERIDIAN CO., LTD.
3550 SW 148 AVENUE
SUITE 110
MIRAMAR, FL 33027 US
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Contact VINOD PODICHETTY
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 08/20/2010
Decision Date 02/25/2011
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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