SteriTrak— 510(k) K203605

Substantially Equivalent

Arbutus Medical, Inc.

FDA 510(k) clearance K203605 for SteriTrak, Substantially Equivalent on 2021-04-23. Applicant: Arbutus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Arbutus Medical, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2020-12-10
Decision date: 2021-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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