AAMI Level 4 Protective; Gown— 510(k) K242689

Substantially Equivalent

Azac Group

FDA 510(k) clearance K242689 for AAMI Level 4 Protective; Gown, Substantially Equivalent on 2025-01-13. Applicant: Azac Group. Device class: 2.

Clearance details

Applicant: Azac Group
Product code: Code QPC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2024-09-06
Decision date: 2025-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: City Of Industry, CA, US

Download summary PDF View on FDA.gov ↗

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