Omnifix Syringe NRFit— 510(k) K241385

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K241385 for Omnifix Syringe NRFit, Substantially Equivalent on 2024-07-13. Applicant: B.Braun Medical, Inc.. Device class: 2.

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code QEH
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2024-05-15
Decision date: 2024-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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