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FDA 510(k) Application Details - K111878
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K111878
Device Name
Surgeon'S Gloves
Applicant
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
TATYANA BOGDAN
Other 510(k) Applications for this Contact
Regulation Number
878.4460
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Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
07/01/2011
Decision Date
09/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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