Mendell Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009998573
• FEI Number: 3009998573
• Name: MENDELL, INC
• Owner & Operator: Mendell, Inc
• Contact Address: 21463 Grenada Avenue ; Lakeville MN 55044 US
• Official Correspondent:
  • Suzanne Bartz
  • 1-952-4695500-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 21463 Grenada Ave ; Lakeville, MN 55044 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
QGA MENDELL, INC	Sizer	2020-04-10
PMN K151900 | MAX MENDELL, INC	VariLift LX	2018-10-22
PMN K100354 | KWP MENDELL, INC	PrimaLOK SP	2018-10-22
PMN K060569 | JWH MENDELL, INC	Constrained Knee Insert Impactor	2014-11-12
PMN K103660 | ODP MENDELL, INC	Breckenridge	2012-12-18
PMN K103660 | MQP MENDELL, INC	Breckenridge	2012-12-18