OpenTex— 510(k) K222549
Substantially EquivalentPurgo Biologics, Inc.
FDA 510(k) clearance K222549 for OpenTex, Substantially Equivalent on 2023-05-11. Applicant: Purgo Biologics, Inc.. Device class: 2.
Clearance details
- Applicant
- Purgo Biologics, Inc.
- Product code
- Code NPK
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seongnam-Si, KR
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