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FDA 510(k) Application Details - K053272
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K053272
Device Name
Surgeon'S Gloves
Applicant
Cardinal Health
1500 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
AMY HOYD
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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
11/23/2005
Decision Date
01/05/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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