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FDA 510(k) Application Details - K111604
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K111604
Device Name
Latex Patient Examination Glove
Applicant
UG GLOBAL RESOURCES SDN BHD
1565 SUNFLOWER AVE.
COSTA MESA, CA 92626 US
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Contact
KENNETH STANTON
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
06/08/2011
Decision Date
06/08/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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