FDA 510(k) Application Details - K003538

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K003538
Device Name Lamp, Infrared, Therapeutic Heating
Applicant LHASA MEDICAL, INC.
234 LIBBEY PKWY.
WEYMOUTH, MA 02189 US
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Contact KYUNG P RIIHIMAKI
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 11/16/2000
Decision Date 06/04/2001
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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