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FDA 510(k) Application Details - K031301
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K031301
Device Name
Surgeon'S Gloves
Applicant
Cardinal Health
1500 WAUKEGAN RD. BLDG. WM
MCGAW PARK, IL 60085 US
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Contact
ERICA SETHI
Other 510(k) Applications for this Contact
Regulation Number
878.4460
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Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2003
Decision Date
10/15/2003
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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