Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004007782

FEI Number

3004007782

Entity Name

ENVOY MEDICAL CORPORATION

City/State/Country

White Bear Lake, MN, US

Establishment Address

4875 White Bear Pkwy, White Bear Lake, MN 55110, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ENVOY MEDICAL CORPORATION (Owner Number: 9092560)

Owner / Operator Contact Address

4875 White Bear Parkway, --, White Bear Lake, MN 55110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P090018

All Registered Proprietary Names

EnvoyCem Esteem

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEA	Cement, Ear, Nose And Throat	Dental	Class 2	872.3275	2008-03-03
OAF	Implant, Hearing, Active, Middle Ear, Totally Implanted	Unknown	Class 3	N/A	2010-07-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENVOY MEDICAL CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042516	Walter Lorenz Surgical, Inc.	OTOMIMIX	2004-11-08

Similar Registrations

Registration Number	Establishment Name	Location
1450662	Isomedix Operations, Inc.	Libertyville, IL, US
3012118649	Ototronix, LLC (Minnesota)	White Bear Township, MN, US
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
1052728	INVOTEC INTERNATIONAL, INC.	Jacksonville, FL, US
3009183442	Cirtec Medical	Enfield, CT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004007782. Last updated year: 2026. Please use registration number 3004007782 when referencing this establishment in official correspondence.