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FDA 510(k) Application Details - K190333
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K190333
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
ConMed Corporation
525 French Road
Utica, NY 13502 US
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Contact
Orjada Dervishleri
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
02/14/2019
Decision Date
03/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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