FDA 510(k) Application Details - K960178

Device Classification Name Surgeon'S Gloves

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510(K) Number K960178
Device Name Surgeon'S Gloves
Applicant WEMBLEY RUBBER PRODUCTS (M) SDN BHD
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR 43900 MY
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Contact YUE WAH CHOW
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 01/16/1996
Decision Date 05/06/1996
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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