NRFit® Caps, Male and Female Neuraxial Tip Caps— 510(k) K201031

Name: FDA 510(k) clearance K201031
Creator: U.S. Food and Drug Administration
Published: 2020-12-16

Substantially Equivalent

International Medical Industries, Inc.

FDA 510(k) clearance K201031 for NRFit® Caps, Male and Female Neuraxial Tip Caps, Substantially Equivalent on 2020-12-16. Applicant: International Medical Industries, Inc.. Device class: 2.

Clearance details

Applicant: International Medical Industries, Inc.
Product code: Code QEH
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2020-04-20
Decision date: 2020-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompano Beach, FL, US

Download summary PDF View on FDA.gov ↗

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