T-PLUS— 510(k) K181893

Substantially Equivalent

Wintecare SA

FDA 510(k) clearance K181893 for T-PLUS, Substantially Equivalent on 2019-01-29. Applicant: Wintecare SA. Device class: 2.

Clearance details

Applicant: Wintecare SA
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2018-07-13
Decision date: 2019-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiasso, CH

Download summary PDF View on FDA.gov ↗

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