Dukal Corporation Level 1 Pediatric Face Mask— 510(k) K210321

Name: FDA 510(k) clearance K210321
Creator: U.S. Food and Drug Administration
Published: 2022-03-29

Substantially Equivalent

Dukal Corporation

FDA 510(k) clearance K210321 for Dukal Corporation Level 1 Pediatric Face Mask, Substantially Equivalent on 2022-03-29. Applicant: Dukal Corporation. Device class: 2.

Clearance details

Applicant: Dukal Corporation
Product code: Code OXZ
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2021-02-04
Decision date: 2022-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, 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.