BiliWrap— 510(k) K243372

Substantially Equivalent

Gerium Medical, Ltd.

FDA 510(k) clearance K243372 for BiliWrap, Substantially Equivalent on 2025-05-29. Applicant: Gerium Medical, Ltd..

Clearance details

Applicant: Gerium Medical, Ltd.
Product code: Code LBI
Advisory panel: General Hospital
Date received: 2024-10-30
Decision date: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yavne, IL

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