Biotex— 510(k) K180992

Substantially Equivalent

Purgo Biologics, Inc.

FDA 510(k) clearance K180992 for Biotex, Substantially Equivalent on 2019-07-16. Applicant: Purgo Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Purgo Biologics, Inc.
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2018-04-16
Decision date: 2019-07-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.