Self-Forming Magnet (Flexagon Plus OTOLoc)— 510(k) K250541

Substantially Equivalent

GI Windows, Inc.

FDA 510(k) clearance K250541 for Self-Forming Magnet (Flexagon Plus OTOLoc), Substantially Equivalent on 2025-08-01. Applicant: GI Windows, Inc..

Clearance details

Applicant: GI Windows, Inc.
Product code: Code SAH
Advisory panel: General, Plastic Surgery
Date received: 2025-02-24
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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