Eight 28 L L C

FDA Filings

This page includes the latest FDA filings for Eight 28 L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015199170
• FEI Number: 3015199170
• Name: EIGHT:28, LLC
• Owner & Operator: Eight:28, LLC
• Contact Address: 8574 TUNBRIDGE WELLS DR S ; Semmes AL 36575 US
• Official Correspondent:
  • Travis Francez
  • x-251-4229525-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8574 TUNBRIDGE WELLS DR S ; Semmes, AL 36575 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
INN EIGHT:28, LLC	Ken-Tec SPD	2018-12-10

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202003043488	Pusan,South Korea -> Mobile, Alabama	STEEL FRAME - CLASS 1 MEDICAL DEVICE COMPONENT	14 PKG