FDA 510(k) Application Details - K960036

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K960036
Device Name Lamp, Infrared, Therapeutic Heating
Applicant HELIO MEDICAL SUPPLIES, INC.
2080-A WALSH AVE.
SANTA CLARA, CA 95050 US
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Contact RICHARD T KOO
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 01/02/1996
Decision Date 06/06/1996
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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