FDA 510(k) Application Details - K033534

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K033534
Device Name Thermometer, Electronic, Clinical
Applicant MINI-MITTER CO., INC.
20300 EMPIRE AVE. BLDG. B-3
BEND, OR 97701 US
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Contact JACK E MCKENZIE
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 11/10/2003
Decision Date 04/22/2004
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 Y



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