FDA 510(k) Application Details - K020464

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K020464
Device Name Lamp, Infrared, Therapeutic Heating
Applicant ROLOR ELECTRONICS CORP.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY TW
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Contact Ke-Min Jen
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 02/12/2002
Decision Date 09/17/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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