FDA 510(k) Application Details - K984039

Device Classification Name Latex Patient Examination Glove

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510(K) Number K984039
Device Name Latex Patient Examination Glove
Applicant CRANBERRY (M) SDN. BHD.
LOT 85, JALAN PORTLAND,
TASEK INDUSTRIAL ESTATE
IPOH PERAK 31400 MY
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Contact CHONG YOON TAT
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 11/12/1998
Decision Date 03/29/1999
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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