GrindCare System— 510(k) K163448

Substantially Equivalent

Sunstar Suisse S.A.

FDA 510(k) clearance K163448 for GrindCare System, Substantially Equivalent on 2017-09-01. Applicant: Sunstar Suisse S.A.. Device class: 2.

Clearance details

Applicant: Sunstar Suisse S.A.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2016-12-08
Decision date: 2017-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Etoy, 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.