Winback Back 3SE— 510(k) K162828

Substantially Equivalent

Winback USA Corp

FDA 510(k) clearance K162828 for Winback Back 3SE, Substantially Equivalent on 2017-09-18. Applicant: Winback USA Corp. Device class: 2.

Clearance details

Applicant: Winback USA Corp
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2016-10-07
Decision date: 2017-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dripping Springs, TX, US

Download summary PDF View on FDA.gov ↗

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