Bistool

FDA Filings

This page includes the latest FDA filings for Bistool. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014664527
• FEI Number: 3014664527
• Name: Priscilla Chung
• Owner & Operator: BISTOOL
• Contact Address: 9, Gwangnaru-ro 6-gil, Seongdong-gu ; Seoul KR-NOTA 04796 KR
• Official Correspondent:
  • Eunhyun Bae
  • 82-2-3446-7688
• 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: 1150 ROOSEVELT, SUITE 200 ; Irvine, CA 92620 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K171851 | MIB Priscilla Chung [BISTOOL]	SOFTXIL	2018-06-29
PMN K171851 BISTOOL	SOFTXIL	2018-03-16