Kaesung Co L T D

FDA Filings

This page includes the latest FDA filings for Kaesung 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: 3006657376
• FEI Number: 3006657376
• Name: KAESUNG CO., LTD.
• Owner & Operator: Kaesung Co., Ltd.
• Contact Address: 33, 246 Beon-gil, Bucheon-ro, Wonmi-gu ; Bucheon-Si KR-41 Gyeonggido 420-806 KR
• US Agent:
  • Robert Thompson
  • A-M Systems
  • 360 6838300 302
  • 360 6833525
  • rthompson@a-msystems.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 33, 246 Beon-gil, Bucheon-ro, Wonmi-gu ; Bucheon-Si Gyeonggido, 420-806 KR
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K063526 | CAH KAESUNG CO., LTD.	ViroMax	2010-04-27
PMN K000654 | CAH KAESUNG CO., LTD.	VBMax	2010-04-27
BYP KAESUNG CO., LTD.	Mouthpiece	2010-04-27
BXJ KAESUNG CO., LTD.	Nose Clip	2010-04-27

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092846418	Pusan,South Korea -> Seattle, Washington	PLASTIC FILTER HOUSING	16 CTN
2020092159101	Pusan,South Korea -> Los Angeles, California	PARTS FOR MOTOR VEHICLES	48 CTN
20200915477	Pusan,South Korea -> Seattle, Washington	PLASTIC FILTER HOUSING	300 CTN
20200915335	Pusan,South Korea -> Seattle, Washington	PLASTIC FILTER HOUSING	300 CTN
2020091487540	Pusan,South Korea -> Los Angeles, California	PARTS FOR MOTOR VEHICLES	49 CTN
2020091486569	Pusan,South Korea -> Los Angeles, California	PARTS FOR GENERATOR	565 BOX
2020091247036	Pusan,South Korea -> Seattle, Washington	PLASTIC FILTER HOUSING	606 CTN
2020091175483	Pusan,South Korea -> Seattle, Washington	PLASTIC FILTER HOUSING	606 CTN