S.I.N. Instrument Kits— 510(k) K201688

Name: FDA 510(k) clearance K201688
Creator: U.S. Food and Drug Administration
Published: 2020-10-21

Substantially Equivalent

S.I.N. - Sistema DE Implante Nacional S.A.

FDA 510(k) clearance K201688 for S.I.N. Instrument Kits, Substantially Equivalent on 2020-10-21. Applicant: S.I.N. - Sistema DE Implante Nacional S.A.. Device class: 2.

Clearance details

Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2020-06-22
Decision date: 2020-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Paulo, BR

Download summary PDF View on FDA.gov ↗

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