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FDA 510(k) Application Details - K081464
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K081464
Device Name
Latex Patient Examination Glove
Applicant
Cardinal Health
1500 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
STEVE TAMSETT
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
05/27/2008
Decision Date
08/28/2008
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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