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FDA 510(k) Application Details - K023979
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K023979
Device Name
Polymer Patient Examination Glove
Applicant
STARMATRIX SDN BHD
10, JALAN SS 1/26
PETALING JAYA, SELANGOR 47300 MY
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Contact
NGAN GOON SENG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
12/02/2002
Decision Date
01/24/2003
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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