Neocis Guidance System (NGS) with Patient Splints (EPS)— 510(k) K203401

Name: FDA 510(k) clearance K203401
Creator: U.S. Food and Drug Administration
Published: 2020-12-15

Substantially Equivalent

Neocis, Inc.

FDA 510(k) clearance K203401 for Neocis Guidance System (NGS) with Patient Splints (EPS), Substantially Equivalent on 2020-12-15. Applicant: Neocis, Inc.. Device class: 2.

Clearance details

Applicant: Neocis, Inc.
Product code: Code PLV
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2020-11-19
Decision date: 2020-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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