FDA 510(k) Application Details - K020019

Device Classification Name Surgeon'S Gloves

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510(K) Number K020019
Device Name Surgeon'S Gloves
Applicant WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR 43900 MY
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Contact YUE W CHOW
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 01/03/2002
Decision Date 01/23/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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