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FDA 510(k) Application Details - K954967
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K954967
Device Name
Latex Patient Examination Glove
Applicant
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
7400 NORTH ORACLE
SUITE 330
TUCSON, AZ 85704 US
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Contact
KATHY SALFINGERE
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
10/30/1995
Decision Date
04/15/1996
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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