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FDA 510(k) Applications Submitted by Calen Souther
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221135
04/19/2022
X-Twist PEEK Suture Anchor
Parcus Medical LLC
K232513
08/18/2023
X-Twist Biocomposite Suture Anchor
Parcus Medical
K212739
08/30/2021
ActiFlip
Parcus Medical LLC.
K193573
12/23/2019
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
Molnlycke Health Care US LLC.
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