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FDA 510(k) Application Details - K051793
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K051793
Device Name
Surgeon'S Gloves
Applicant
ANSELL HEALTHCARE PRODUCTS, LLC
1635 INDUSTRIAL ROAD
DOTHAN, AL 36303 US
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Contact
CYNTHIA A INGRAM
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
07/01/2005
Decision Date
08/17/2005
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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