FDA 510(k) Application Details - K981708

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K981708
Device Name Thermometer, Electronic, Clinical
Applicant EXCEL PORCELAIN PRODUCTS
1065 SW 30TH AVE.
DEERFIELD BEACH, FL 33442 US
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Contact ANDREW J PIETROBONO
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 04/27/1998
Decision Date 07/23/1998
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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