Haenaem Co L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3013950957
• FEI Number: 3013950957
• Name: SEOK WOO KIM
• Owner & Operator: Haenaem Co., Ltd.
• Contact Address: 194, Jisan-ro 175beon-gil, Jinwi-myeon ; Pyeongtaek-si KR-41 Gyeonggido 17718 KR
• US Agent:
  • SEOK WOO KIM
  • KMC USA, INC
  • 847 9241545
  • kmc.usa@kmcerti.com
• Importing Logistics Registration:
  • Importer: Plus Global
  • Address: 300 Atwood ; Pittsburgh, PA 15213 UNITED STATES
  • Phone: 1 412 5128802
  • Importer Type: AGENT
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5450 ASTOR LANE #203 ; Rolling Mdws, IL 60008 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Trephine kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Total remove kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Total Sinus Kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Total Haenaem Bur Kit (HNTOK-100)	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Tissue punch kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Solid Screw Mini Kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	One drilling system kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	One Drilling System Kit - Advanced	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Neat Tissue Former Kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Lateral Approach Sinus Kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Initial kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Haenaem Bur Kit (HNODK-100)	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Double A Guide Kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Crestal Approach Sinus Pro Kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Crestal Approach Sinus Kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Burr kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Bone expander kit	2017-09-05
NDP SEOK WOO KIM [Haenaem Co., Ltd.]	Bone collector kit	2017-09-05