INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE— 510(k) K013225

Name: FDA 510(k) clearance K013225
Creator: U.S. Food and Drug Administration
Published: 2001-12-26

Substantially Equivalent

Medafor, Inc.

FDA 510(k) clearance K013225 for INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE, Substantially Equivalent on 2001-12-26. Applicant: Medafor, Inc.. Device class: 1.

Clearance details

Applicant: Medafor, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2001-09-27
Decision date: 2001-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, 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.