FDA 510(k) Application Details - K061080

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K061080
Device Name Lamp, Infrared, Therapeutic Heating
Applicant LHASA OMS, INC.
230 LIBBEY PKWY.
WEYMOUTH, MA 02189 US
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Contact MARK W SHEEHAN
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 04/18/2006
Decision Date 06/14/2006
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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