OpenTex— 510(k) K222549

Substantially Equivalent

Purgo Biologics, Inc.

FDA 510(k) clearance K222549 for OpenTex, Substantially Equivalent on 2023-05-11. Applicant: Purgo Biologics, Inc..

Clearance details

Applicant: Purgo Biologics, Inc.
Product code: Code NPK
Advisory panel: Dental
Date received: 2022-08-23
Decision date: 2023-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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