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FDA 510(k) Application Details - K991776
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K991776
Device Name
Polymer Patient Examination Glove
Applicant
SELTOM PACIFIC SDN. BHD.
LOT 25, JALAN PJS 7/17
SUNWAY INDUSTRIAL PARK
PETALING JAYA, SELANGOR 46150 MY
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Contact
S. SEGARAN
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
05/25/1999
Decision Date
08/11/1999
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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