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FDA 510(k) Applications Submitted by SHAWNA M. ROSE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170803
03/17/2017
HydroMARK Breast Biopsy Site Markers
Devicor Medical Products, Inc.
K161021
04/12/2016
HydroMARK Breast Biopsy Site Marker
DEVICOR MEDICAL PRODUCTS, INC.
K153709
12/23/2015
Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet
DEVICOR MEDICAL PRODUCTS, INC.
K112411
08/22/2011
MAMMOTOME ELITE BIOPSY SYSTEM
DEVICOR MEDICAL PRODUCTS INC.
K123259
10/18/2012
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
DEVICOR MEDICAL PRODUCTS, INC.
K152989
10/13/2015
Mammotome revolve Dual Vacuum Assist Biopsy System
DEVICOR MEDICAL PRODUCTS, INC.
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