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FDA 510(k) Applications Submitted by Hologic, INC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150169
01/26/2015
Sertera Biopsy Device
Hologic, INC
K180233
01/29/2018
Eviva Stereotactic Guided Breast Biopsy System
Hologic, Inc
K152723
09/22/2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
HOLOGIC, INC
K202294
08/13/2020
Affirm Contrast Biopsy
Hologic, Inc
K181974
07/24/2018
MyoSure XL Tissue Removal Device for Fluent
Hologic, Inc
K182006
07/27/2018
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
Hologic, Inc
K182052
07/31/2018
Omni Instrument Tray
Hologic, Inc
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