FDA 510(k) Application Details - K002701

Device Classification Name Latex Patient Examination Glove

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510(K) Number K002701
Device Name Latex Patient Examination Glove
Applicant ALLIANCE RUBBER PRODUCTS SDN. BHD.
LOT 2716&2720, MK 7, KAWASAN
PERINDUSTRIAN BUKIT PANCHOR
NIBONG TEBAL, PULAU PINANG 14300 MY
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Contact CHUA HOOI KOON
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 08/30/2000
Decision Date 09/13/2000
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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