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FDA 510(k) Application Details - K173304
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K173304
Device Name
Surgeon'S Gloves
Applicant
Lucenxia Prescience Ag
Rathausstrasse 7
Baar 6341 CH
Other 510(k) Applications for this Company
Contact
Robert Hill
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
10/18/2017
Decision Date
04/30/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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