FDA 510(k) Application Details - K990901

Device Classification Name Latex Patient Examination Glove

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510(K) Number K990901
Device Name Latex Patient Examination Glove
Applicant APL PRODUCTS SDN. BHD.
LOT 8961 & 8964
JALAN BENUAS
AYER TAWAR,PERAK DARUL RIDZUAN 32400 MY
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Contact SON HONG LEE
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 03/18/1999
Decision Date 05/04/1999
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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