Kerecis Gingiva Graft— 510(k) K192612
Substantially EquivalentKerecis Limited
FDA 510(k) clearance K192612 for Kerecis Gingiva Graft, Substantially Equivalent on 2020-11-13. Applicant: Kerecis Limited. Device class: 2.
Clearance details
- Applicant
- Kerecis Limited
- Product code
- Code NPL
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Isafjordur, IS
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