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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diagnostic light, soft tissue detector
510(k) Number K090135
Device Name TRIMIRA IDENTAFI 3000
Applicant
REMICALM, LLC
952 ECHO LANE, SUITE 333
HOUSTON,  TX  77024 -2758
Applicant Contact DAVID B JONES
Correspondent
REMICALM, LLC
952 ECHO LANE, SUITE 333
HOUSTON,  TX  77024 -2758
Correspondent Contact DAVID B JONES
Regulation Number872.6350
Classification Product Code
NXV  
Date Received01/21/2009
Decision Date 02/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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