FDA 510(k) Application Details - K023978

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K023978
Device Name Polymer Patient Examination Glove
Applicant STARMATRIX SDN BHD
10, JALAN SS 1/26
PETALING JAYA, SELANGOR 47300 MY
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Contact NGAN BOON SENG
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 12/02/2002
Decision Date 01/24/2003
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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