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FDA 510(k) Application Details - K001056
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K001056
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE, WA 98108 US
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Contact
JOSEPH P STEFANILE
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Regulation Number
890.5500
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Classification Product Code
ILY
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Date Received
04/03/2000
Decision Date
09/29/2000
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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