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FDA 510(k) Application Details - K031113
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K031113
Device Name
Vinyl Patient Examination Glove
Applicant
ELITE INTERNATIONAL, INC.
18709 GREENBAY DR.
ROWLAND HEIGHTS, CA 91748 US
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Contact
BOBBY LING
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
04/08/2003
Decision Date
06/10/2003
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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