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FDA 510(k) Application Details - K955425
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K955425
Device Name
Latex Patient Examination Glove
Applicant
DASH MEDICAL GLOVES SDN BHD
LOT 16, LENGKONGAN HISHAMUDDIN
KAWASAN 20, SELAT KLANG UTARA,
PELABUHAN KLANG, SELANGOR 42000 MY
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Contact
KHOO SEANG HOE
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
11/28/1995
Decision Date
12/30/1996
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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