FDA 510(k) Application Details - K993500

Device Classification Name Latex Patient Examination Glove

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510(K) Number K993500
Device Name Latex Patient Examination Glove
Applicant BESGLOVE MEDICARE SDN. BHD.
LOT 6, JALAN P/2A
BANGI INDUSTRIAL ESTATE
KAJANG,SELANGOR DARUL,EHASAN 43000 MY
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Contact LEE AIK LIM
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 10/15/1999
Decision Date 12/02/1999
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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