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FDA 510(k) Application Details - K993664
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K993664
Device Name
Vinyl Patient Examination Glove
Applicant
TOP GLOVE SDN. BHD.
LOT 4968, BT 6, JALAN TERATAI
OFF JALAN MERU
KLANG, SELANGOR 41050 MY
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Contact
WEE-CHAI LIM
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
10/29/1999
Decision Date
01/11/2000
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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