ADAPT Tissue— 510(k) K200566

Substantially Equivalent

Admedus Regen Pty, Ltd.

FDA 510(k) clearance K200566 for ADAPT Tissue, Substantially Equivalent on 2020-04-03. Applicant: Admedus Regen Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Admedus Regen Pty, Ltd.
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2020-03-04
Decision date: 2020-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Malaga, 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.