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FDA 510(k) Application Details - K090828
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K090828
Device Name
Polymer Patient Examination Glove
Applicant
ULTRAWIN SDN BHD
LOT 2, PESIARAN PERINDUSTRIAN
KANTHAN 2
CHEMOR, PERAK 31200 MY
Other 510(k) Applications for this Company
Contact
MAH SIEW HOE
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2009
Decision Date
07/28/2009
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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