FDA 510(k) Application Details - K063046

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K063046
Device Name Polymer Patient Examination Glove
Applicant HARTALEGA SDN BHD
NO. 7, KAWASAN PERUSAHAAN
SURIA
BATAN BERJUNTAI 45600 MY
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Contact NURUL A KONG
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 10/04/2006
Decision Date 11/17/2006
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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