FDA 510(k) Applications Submitted by Katy Austin

FDA 510(k) Number Submission Date Device Name Applicant
K240527 02/23/2024 HydroMARKÖ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) Devicor Medical Products, Inc.
K221961 07/05/2022 HydroMARK Plus Breast Biopsy Site Marker Devicor Medical Products, Inc.
K232615 08/28/2023 LumiMARKÖ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARKÖ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARKÖ Biopsy Site Marker (LM0215R (Rose shape)) Devicor Medical Products, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact