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FDA 510(k) Application Details - K152428
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K152428
Device Name
Surgeon'S Gloves
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
Other 510(k) Applications for this Company
Contact
JENNIFER MASON
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/26/2015
Decision Date
03/31/2016
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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