Kerecis SecureMesh— 510(k) K153364
Substantially EquivalentKerecis Limited
FDA 510(k) clearance K153364 for Kerecis SecureMesh, Substantially Equivalent on 2016-08-19. Applicant: Kerecis Limited. Device class: 2.
Clearance details
- Applicant
- Kerecis Limited
- Product code
- Code OXE
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Isafjordur, IS
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