Kerecis Oral— 510(k) K213904

Substantially Equivalent

Kerecis

FDA 510(k) clearance K213904 for Kerecis Oral, Substantially Equivalent on 2022-09-30. Applicant: Kerecis. Device class: 2.

Clearance details

Applicant: Kerecis
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2021-12-14
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Isafjordur, IS

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.