Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit— 510(k) K200734

Substantially Equivalent

Sirius Medical Systems B.V.

FDA 510(k) clearance K200734 for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit, Substantially Equivalent on 2021-02-24. Applicant: Sirius Medical Systems B.V..

Clearance details

Applicant: Sirius Medical Systems B.V.
Product code: Code PBY
Advisory panel: General, Plastic Surgery
Date received: 2020-03-20
Decision date: 2021-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

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