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FDA 510(k) Application Details - K103714
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K103714
Device Name
Surgeon'S Gloves
Applicant
ANSELL HEALTHCARE PRODUCTS, LLC
555 ZANG STREET, SUITE 100
LAKEWOOD, CO 80228 US
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Contact
MARY L ARMSTRONG
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
12/21/2010
Decision Date
07/07/2011
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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