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FDA 510(k) Application Details - K220091
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K220091
Device Name
Mesh, Surgical, Polymeric
Applicant
Xiros Ltd
Springfield House Lane, Whitehouse Lane
Leeds LS17 7UE GB
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Contact
Steve Curran
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
01/12/2022
Decision Date
08/26/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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