Osstem Implant Co L T D Chair Business

FDA Filings

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

FDA Registration(s)

• Registration Number: 3015980207
• FEI Number: 3015980207
• Name: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
• Owner & Operator: Osstem Implant Co., Ltd.
• Contact Address: 135 Gasan digital 2-ro, Geumcheon-gu ; Seoul KR-11 Seoul Teugbyeolsi 153803 KR
• Official Correspondent:
  • Tae-Gwan Eom
  • 82-070-43940469-x
• US Agent:
  • Peter Lee
  • HIOSSEN, Inc.
  • 267 7597031
  • peter.l@hiossen.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 192, Haebong-ro, Danwon-gu ; Ansan-si Gyeonggido, 15428 KR
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

• Registration Number: 3012411108
• FEI Number: 3012411108
• Name: OSSTEM IMPLANT Co., Ltd. Chair Business
• Owner & Operator: Osstem Implant Co., Ltd.
• Contact Address: 135 Gasan digital 2-ro, Geumcheon-gu ; Seoul KR-11 Seoul Teugbyeolsi 153803 KR
• Official Correspondent:
  • Tae-Gwan Eom
  • 82-070-43940469-x
• US Agent:
  • PETER LEE
  • HIOSSEN INC.
  • 267 7597031
  • 267 7597004
  • peter.l@hiossen.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 135 Gasan digital 2-ro, Geumcheon-gu ; Seoul Seoul Teugbyeolsi, 08504 KR
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K183347 | EIA OSSTEM IMPLANT Co., Ltd. Chair Business [Osstem Implant Co., Ltd.]	K3 V1.2	2019-09-10
PMN K183347 | EIA OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS [Osstem Implant Co., Ltd.]	K3 V1.2	2019-09-10
NRU OSSTEM IMPLANT Co., Ltd. Chair Business [Osstem Implant Co., Ltd.]	K3-Chair only	2019-02-20
NRU OSSTEM IMPLANT Co., Ltd. Chair Business [Osstem Implant Co., Ltd.]	K3 Headrest Seat Ass'y (YHRSA03)	2019-02-20
NRU OSSTEM IMPLANT Co., Ltd. Chair Business [Osstem Implant Co., Ltd.]	Headrest Ass'y 2-joint (K3HR)	2019-02-20
NRU OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS [Osstem Implant Co., Ltd.]	K3-Chair only	2019-02-20
NRU OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS [Osstem Implant Co., Ltd.]	K3 Headrest Seat Ass'y (YHRSA03)	2019-02-20
NRU OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS [Osstem Implant Co., Ltd.]	Headrest Ass'y 2-joint (K3HR)	2019-02-20
PMN K173905 | KMW OSSTEM IMPLANT Co., Ltd. Chair Business [Osstem Implant Co., Ltd.]	SM3	2019-01-14
PMN K173905 | EGS OSSTEM IMPLANT Co., Ltd. Chair Business [Osstem Implant Co., Ltd.]	SM3	2019-01-14
PMN K173905 | EBW OSSTEM IMPLANT Co., Ltd. Chair Business [Osstem Implant Co., Ltd.]	SM3	2019-01-14
PMN K152830 | EIA OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS [Osstem Implant Co., Ltd.]	K3	2017-04-26