Back 3 COLOR— 510(k) K214090

Substantially Equivalent

Swims America Corp

FDA 510(k) clearance K214090 for Back 3 COLOR, Substantially Equivalent on 2022-11-01. Applicant: Swims America Corp. Device class: 2.

Clearance details

Applicant: Swims America Corp
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2021-12-28
Decision date: 2022-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

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