FDA 510(k) Application Details - K990686

Device Classification Name Latex Patient Examination Glove

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510(K) Number K990686
Device Name Latex Patient Examination Glove
Applicant TOWER RUBBER INDUSTRIES SDN. BHD.
LOT 18, JALAN LINGKARAN SULTAN
HISHAMUDDIN, KAW. PERUSAHAAN
SELAT KLANG UTARA, PORT KLANG 42000 MY
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Contact S. VICKNESWARAN
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 03/03/1999
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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