MCKEON PRODUCTS, INC.

FDA Device Registration & Listing · WARREN, MI, US · Registration 1818945

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1818945
FEI Number
1818945
Entity Name
MCKEON PRODUCTS, INC.
City/State/Country
WARREN, MI, US
Establishment Address
25460 GUENTHER, WARREN, MI 48091, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
MCKEON PRODUCTS, INC. (Owner Number: 1818945)
Owner / Operator Contact Address
25460 GUENTHER, --, Warren, MI 48091, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191033
PMA Number
N/A

All Registered Proprietary Names

Mack's Earplugs AIRMAX LunaGuard Nighttime Dental Guard

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EWD Protector, Hearing (Insert) Unknown Class U N/A 2008-06-04
LWF Dilator, Nasal Ear, Nose, Throat Class 1 874.3900 2013-10-21
OBR Mouthguard, Over-The-Counter Unknown Class U N/A 2019-10-25

Official Correspondent

DEVIN BENNER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MCKEON PRODUCTS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1818945. Last updated year: 2026. Please use registration number 1818945 when referencing this establishment in official correspondence.
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