NAJA Gastrointestinal Catheter— 510(k) K223890

Name: FDA 510(k) clearance K223890
Creator: U.S. Food and Drug Administration
Published: 2023-06-16

Substantially Equivalent

Chess Medical, Inc.

FDA 510(k) clearance K223890 for NAJA Gastrointestinal Catheter, Substantially Equivalent on 2023-06-16. Applicant: Chess Medical, Inc.. Device class: 2.

Clearance details

Applicant: Chess Medical, Inc.
Product code: Code FGD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2022-12-27
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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