FDA 510(k) Application Details - K023522

Device Classification Name Latex Patient Examination Glove

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510(K) Number K023522
Device Name Latex Patient Examination Glove
Applicant EVER-MORE LATEX PRODUCTS SDN BHD
LOT 555, 6 3/4 MILE
JALAN GANGSA, DURIAN TUNGGALL
MELAKA 76100 MY
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Contact CHIA MENG CHANG
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 10/21/2002
Decision Date 11/29/2002
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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