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FDA 510(k) Application Details - K071209
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K071209
Device Name
Latex Patient Examination Glove
Applicant
HIGH MOMENTUM SDN BHD
BANDAR BUKIT TINGGI KLANG
PELABUHAN KLANG
SELANGOR DAURL EHSAN 42100 MY
Other 510(k) Applications for this Company
Contact
HUE K FAH
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
05/01/2007
Decision Date
07/25/2007
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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