SoloSmart Injection Pen Adapter (SoloSmart®)— 510(k) K231820

Name: FDA 510(k) clearance K231820
Creator: U.S. Food and Drug Administration
Published: 2024-01-12

Substantially Equivalent

Biocorp Production

FDA 510(k) clearance K231820 for SoloSmart Injection Pen Adapter (SoloSmart®), Substantially Equivalent on 2024-01-12. Applicant: Biocorp Production. Device class: 2.

Clearance details

Applicant: Biocorp Production
Product code: Code QOG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2023-06-21
Decision date: 2024-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Issoire, FR

Download summary PDF View on FDA.gov ↗

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