FDA 510(k) Application Details - K032714

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K032714
Device Name Thermometer, Electronic, Clinical
Applicant LUMISCOPE CO., INC.
122 TICES LN.
EAST BRUNSWICK, NJ 08816 US
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Contact MARIO MANZANO
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/02/2003
Decision Date 10/22/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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