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FDA 510(k) Applications Submitted by Guy Sevigny
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170557
02/24/2017
GenePOC GBS LB
GenePOC Inc.
K170558
02/24/2017
revogene
GenePOC Inc.
K191150
05/01/2019
Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc.
K191996
07/26/2019
BC Reflex Uni Knee System
Bodycad Laboratories, Inc.
K172569
08/25/2017
GenePOC CDiff
GenePOC Inc.
K193614
12/26/2019
FINE Osteotomy around the knee
Bodycad Laboratories, Inc.
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