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FDA 510(k) Application Details - K171680
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K171680
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
Xiros Ltd
Springfield House, Whitehouse Lane
Leeds LS197UE GB
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Contact
Stephen Seed
Other 510(k) Applications for this Contact
Regulation Number
878.5000
More FDA Info for this Regulation Number
Classification Product Code
GAT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/06/2017
Decision Date
06/30/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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