K243289

Substantially Equivalent

ADDNOX (BPSPM1)

Applicant: Nu Eyne Co., Ltd.
Product code: QGL
Advisory panel: Neurology
Date received: 2024-10-18
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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Data sourced from openFDA. This site is unofficial and independent of the FDA.