FDA 510(k) Applications Submitted by Yoo Hwan Park

FDA 510(k) Number Submission Date Device Name Applicant
K143431 12/01/2014 Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) i-codi Co., Ltd
K150079 01/15/2015 Regenomer« Syringe, Regenomer« Plug, Regenomer« Block NIBEC CO, LTD
K210147 01/21/2021 Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield Unicoglobal, Inc.
K203539 12/03/2020 Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) Unicoglobal, Inc.


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