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FDA 510(k) Application Details - K974662
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K974662
Device Name
Latex Patient Examination Glove
Applicant
IDEAL QUALITY SDN., BHD.
JALAN SUNGAI SEMBILANG
45800 JERAM
SELANGOR DARUL ESHAN MY
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Contact
LIM L BUNG
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Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
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More FDA Info for this Product Code
Date Received
12/15/1997
Decision Date
04/02/1998
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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