FDA 510(k) Application Details - K103407

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K103407
Device Name Thermometer, Electronic, Clinical
Applicant COTRONIC MANUFACTURING
23 JOSIAH AVE
SAN FRANCISCO, CA 94112 US
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Contact YAN DUR LIN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 11/19/2010
Decision Date 05/13/2011
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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