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FDA 510(k) Application Details - K072802
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K072802
Device Name
Latex Patient Examination Glove
Applicant
ULTRAWIN SDN BHD
12-A, TAM,AN ROS JALAN SULTAN
ABDULLAH
TELUK INTAN 36000 MY
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Contact
SIEW-HOE MAH
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2007
Decision Date
02/29/2008
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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