FDA 510(k) Application Details - K990526

Device Classification Name Latex Patient Examination Glove

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510(K) Number K990526
Device Name Latex Patient Examination Glove
Applicant SSN GLOVES (M) SDN BHD
LOT 147, JALAN SELVADURAI,
OFF JALAN IPOH
KUALA LUMPUR 51200 MY
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Contact ANG TECK LEONG
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 02/19/1999
Decision Date 04/23/1999
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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