Data / Medical devices / United States / Mckeon Products, Inc.
Mckeon Products, Inc.: FDA-registered device maker in Warren, MI, United States, 1 510(k) clearance
Mckeon Products, Inc. is registered with the FDA (registration 1818945) in Warren, MI, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 5, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1818945
- Address
- 25460 Guenther, Warren, MI, United States, 48091
- Owner or operator
- MCKEON PRODUCTS, INC. (1818945)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 4, 2008
- Registered through
- 2027
- Brand names listed
- AIRMAX, LunaGuard Nighttime Dental Guard, Mack's Earplugs
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Nasal | LWF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Repackager or relabeler | accessdata.fda.gov |
| Protector, Hearing (Insert) | EWD | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2019 | K191033 | LunaGuard Nighttime Dental Protector | OBR | Substantially Equivalent | Mckeon Products | accessdata.fda.gov |
Compare with other makers
- All makers of Protector, Hearing (Insert)
- All makers of Dilator, Nasal
- All makers of Mouthguard, Over-The-Counter
Updated August 5, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.