POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT— 510(k) K122494

Name: FDA 510(k) clearance K122494
Creator: U.S. Food and Drug Administration
Published: 2013-03-27

Substantially Equivalent

Hemostasis, LLC

FDA 510(k) clearance K122494 for POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT, Substantially Equivalent on 2013-03-27. Applicant: Hemostasis, LLC. Device class: 1.

Clearance details

Applicant: Hemostasis, LLC
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2012-08-16
Decision date: 2013-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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.