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FDA 510(k) Application Details - K151694
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K151694
Device Name
Surgeon'S Gloves
Applicant
ANSELL HEALTHCARE PRODUCTS, LLC
111 Wood Avenue South, Suite 210
Iselin, NJ 08830 US
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Contact
Vasudev Dobariya
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
06/23/2015
Decision Date
03/09/2016
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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