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FDA 510(k) Application Details - K983608
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K983608
Device Name
Latex Patient Examination Glove
Applicant
YTY INDUSTRY (MANJUNG) SDN. BHD.
PO BOX 4341
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
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More FDA Info for this Product Code
Date Received
10/14/1998
Decision Date
11/05/1998
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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