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FDA 510(k) Application Details - K990686
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K990686
Device Name
Latex Patient Examination Glove
Applicant
TOWER RUBBER INDUSTRIES SDN. BHD.
LOT 18, JALAN LINGKARAN SULTAN
HISHAMUDDIN, KAW. PERUSAHAAN
SELAT KLANG UTARA, PORT KLANG 42000 MY
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Contact
S. VICKNESWARAN
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
03/03/1999
Decision Date
05/04/1999
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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