FDA 510(k) Application Details - K974832

Device Classification Name Latex Patient Examination Glove

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510(K) Number K974832
Device Name Latex Patient Examination Glove
Applicant SERVICOM SERVICES SDN BHD
BANGUNAN ANGKASA RAYA
SUITE GH, 17TH FL.
JANAN AMPANG, KUALA LUMPUR 50450 MY
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Contact N.S KUMAR
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 12/24/1997
Decision Date 02/11/1998
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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