Hironic Co L T D

FDA Filings

This page includes the latest FDA filings for Hironic Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

149980

DUNS 557803630

FDA Registration(s)

• Registration Number: 3014980461
• FEI Number: 3014980461
• Name: HIRONIC CO., LTD.
• Owner & Operator: HIRONIC Co., Ltd.
• Contact Address: 19F, 767, Sinsu-ro, Suji-gu ; Yongin-Si KR-41 Gyeonggido 16827 KR
• Official Correspondent:
  • Jin-U Lee
  • 82-31-5257815-x
• US Agent:
  • Priscilla Chung
  • LK Consulting Group USA, Inc.
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 19F, 767, Sinsu-ro, Suji-gu ; Yongin-Si Gyeonggido, 16827 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800016213027 Hironic Co., ltd.	SILKRO	2024-07-08
PMN K210084 Hironic Co., Ltd	SILKRO	2022-06-03
PMN K173676 | PBX HIRONIC CO., LTD.	A-Fit	2018-11-12
PMN K173676 | GEX HIRONIC CO., LTD.	A-Fit	2018-11-12
PMN K173676 HIRONIC Co., Ltd.	A-FIT	2018-09-14