Human Tecar HCR 1002— 510(k) K181211

Substantially Equivalent

Unibell S.R.L

FDA 510(k) clearance K181211 for Human Tecar HCR 1002, Substantially Equivalent on 2018-09-10. Applicant: Unibell S.R.L. Device class: 2.

Clearance details

Applicant: Unibell S.R.L
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2018-05-07
Decision date: 2018-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calco, IT

Download summary PDF View on FDA.gov ↗

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