StarPore— 510(k) K200532

Substantially Equivalent

Anatomics Pty, Ltd.

FDA 510(k) clearance K200532 for StarPore, Substantially Equivalent on 2020-06-02. Applicant: Anatomics Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Anatomics Pty, Ltd.
Product code: Code JOF
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2020-03-02
Decision date: 2020-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bentleigh East, AU

Download summary PDF View on FDA.gov ↗

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