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FDA 510(k) Application Details - K932283
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K932283
Device Name
Latex Patient Examination Glove
Applicant
EAC RUBBER INDUSTRIES (M) SDN. BHD.
P.O. BOX 240
46720 PETALING JAYA
MALAYSIA MY
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Contact
EWE HUM
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
05/07/1993
Decision Date
05/02/1994
Decision
SE - Substantially Equivalent
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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