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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K033967
FOIA Releasable 510(k) K033967
Device Name TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
Applicant
Flir Systems
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Applicant Contact PAUL DRYDEN
Correspondent
Flir Systems
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Correspondent Contact PAUL DRYDEN
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received12/22/2003
Decision Date 03/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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