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FDA 510(k) Application Details - K051681
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K051681
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
CARE ELECTRONICS, INC.
4700 STERLING DR., SUITE D
BOULDER, CO 80301 US
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THOMAS O MOODY
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Regulation Number
890.5500
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Classification Product Code
ILY
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Date Received
06/23/2005
Decision Date
07/27/2005
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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