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Skytron, LLC Warning Letter Details

Warning Letter

Skytron, LLC

Skytron, LLC, 5085 Corporate Exchange Blvd SE Grand Rapids , MI 49512 United States, (b)(6)@Skytron.com

Issue DateMay 19, 2026

FEI NumberN/A

Violations3

CountryUnited States

Issuing Office

Center for Devices and Radiological Health

Product Type

Medical Devices

Status

Open

Subject

Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

Skytron, LLC FDA Warning Letter, May 19, 2026