EveryWare— 510(k) K242485

Substantially Equivalent

Breas Medical AB

FDA 510(k) clearance K242485 for EveryWare, Substantially Equivalent on 2025-05-20. Applicant: Breas Medical AB.

Clearance details

Applicant: Breas Medical AB
Product code: Code MOD
Advisory panel: Anesthesiology
Date received: 2024-08-21
Decision date: 2025-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molnlycke, SE

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