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FDA 510(k) Application Details - K043508
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K043508
Device Name
Surgeon'S Gloves
Applicant
ANSELL HEALTHCARE PRODUCTS LLC
1635 INDUSTRIAL ROAD
DOTHAN, AL 36303 US
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Contact
LON D MCILVAIN
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
12/20/2004
Decision Date
01/19/2005
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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