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FDA 510(k) Application Details - K211563
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K211563
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
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
05/20/2021
Decision Date
08/13/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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