THE Cover— 510(k) K230091

Substantially Equivalent

Purgo Biologics, Inc.

FDA 510(k) clearance K230091 for THE Cover, Substantially Equivalent on 2023-10-06. Applicant: Purgo Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Purgo Biologics, Inc.
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2023-01-12
Decision date: 2023-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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