Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe— 510(k) K232943

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K232943 for Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe, Substantially Equivalent on 2024-05-31. Applicant: Smiths Medical Asd, Inc.. Device class: 2.

Clearance details

Applicant
Smiths Medical Asd, Inc.
Product code
Code QNQ
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
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