FDA 510(k) Application Details - K042532

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K042532
Device Name Lamp, Infrared, Therapeutic Heating
Applicant BIOCARE SYSTEMS, INC.
518 17TH STREET
SUITE 1350
DENVER, CO 80202 US
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Contact CLAY ANSELMO
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 09/17/2004
Decision Date 12/13/2004
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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