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FDA 510(k) Application Details - K190915
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K190915
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Oxford Performance Materials, Inc.
30 South Satellite Road
South Windsor, CT 06074 US
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Contact
Andrus Maandi
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2019
Decision Date
07/03/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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