Epi-Stop Nasal Gel/epistaxis pack— 510(k) K230142

Name: FDA 510(k) clearance K230142
Creator: U.S. Food and Drug Administration
Published: 2023-03-22

Substantially Equivalent

Biomed Ent, Inc.

FDA 510(k) clearance K230142 for Epi-Stop Nasal Gel/epistaxis pack, Substantially Equivalent on 2023-03-22. Applicant: Biomed Ent, Inc.. Device class: 1.

Clearance details

Applicant: Biomed Ent, Inc.
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2023-01-18
Decision date: 2023-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.