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FDA 510(k) Applications Submitted by Debbie Fazen
FDA 510(k) Number
Submission Date
Device Name
Applicant
K181151
05/01/2018
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
Ethicon Inc
K163152
11/10/2016
PROLENE Soft Polypropylene Mesh
Ethicon, Inc.
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