FDA 510(k) Application Details - K003313

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K003313
Device Name Thermometer, Electronic, Clinical
Applicant THE KENDALL COMPANY
444 MCDONNELL BLVD.
HAZELWOOD, MO 63042 US
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Contact KELLY J ROWLAND
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 10/23/2000
Decision Date 01/11/2001
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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