FDA 510(k) Application Details - K983406

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K983406
Device Name Thermometer, Electronic, Clinical
Applicant BANTA HEALTHCARE GROUP, LTD.
570 ENTERPRISE DR.
P.O. BOX 806
NEENAH, WI 54957-0806 US
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Contact RICHARD PEPPARD
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/28/1998
Decision Date 10/19/1998
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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