Kerecis SecureMesh— 510(k) K153364

Substantially Equivalent

Kerecis Limited

FDA 510(k) clearance K153364 for Kerecis SecureMesh, Substantially Equivalent on 2016-08-19. Applicant: Kerecis Limited.

Clearance details

Applicant: Kerecis Limited
Product code: Code OXE
Advisory panel: General, Plastic Surgery
Date received: 2015-11-20
Decision date: 2016-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Isafjordur, IS

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