Kerecis Reconstruct— 510(k) K202430

Substantially Equivalent

Kerecis Limited

FDA 510(k) clearance K202430 for Kerecis Reconstruct, Substantially Equivalent on 2021-05-02. Applicant: Kerecis Limited.

Clearance details

Applicant: Kerecis Limited
Product code: Code OXH
Advisory panel: General, Plastic Surgery
Date received: 2020-08-25
Decision date: 2021-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Isafjordur, IS

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