Elitone for Men— 510(k) K253285

Substantially Equivalent

Elidah, Inc.

FDA 510(k) clearance K253285 for Elitone for Men, Substantially Equivalent on 2026-01-23. Applicant: Elidah, Inc..

Clearance details

Applicant: Elidah, Inc.
Product code: Code QAJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-29
Decision date: 2026-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, CT, US

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