FDA 510(k) Application Details - K002448

Device Classification Name Latex Patient Examination Glove

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510(K) Number K002448
Device Name Latex Patient Examination Glove
Applicant OON CORP. RESOURCES
59 SENAWANG INDUSTRIAL ESTATE
SEREMBAN 70450 MY
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Contact CLEMENT K K OON
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 08/09/2000
Decision Date 09/11/2000
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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