CardioCel 3D— 510(k) K170951

Substantially Equivalent

Admedus Regen Pty, Ltd.

FDA 510(k) clearance K170951 for CardioCel 3D, Substantially Equivalent on 2017-04-28. Applicant: Admedus Regen Pty, Ltd..

Clearance details

Applicant: Admedus Regen Pty, Ltd.
Product code: Code PSQ
Advisory panel: Cardiovascular
Date received: 2017-03-31
Decision date: 2017-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Malaga, AU

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