FDA 510(k) Application Details - K915140

Device Classification Name Latex Patient Examination Glove

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510(K) Number K915140
Device Name Latex Patient Examination Glove
Applicant MEDIFLEX INTL.
19 BUTTERFIELD TRAIL BLVD.
EL PASO, TX US
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Contact ORLANDO CORDOVA
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 11/13/1991
Decision Date 02/11/1992
Decision KD - Substantially Equivalent - Kit with Drugs
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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