FDA 510(k) Application Details - K952001

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K952001
Device Name Thermometer, Electronic, Clinical
Applicant GEON CORP.
50 GORDON DR.
SYOSSET, NY 11791 US
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Contact ILENE MANDELBAUM
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 04/28/1995
Decision Date 10/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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