FDA 510(k) Application Details - K033967

Device Classification Name System, Telethermographic (Adjunctive Use)

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510(K) Number K033967
Device Name System, Telethermographic (Adjunctive Use)
Applicant FLIR SYSTEMS
6329 W. WATERVIEW CT.
MCCORDSVILLE, IN 46055-9501 US
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Contact PAUL DRYDEN
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Regulation Number 884.2980

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Classification Product Code LHQ
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Date Received 12/22/2003
Decision Date 03/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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