EPI-STOP EPISTAXIS CATHETER— 510(k) K972077

Name: FDA 510(k) clearance K972077
Creator: U.S. Food and Drug Administration
Published: 1997-06-26

Substantially Equivalent

Boston Medical Products, Inc.

FDA 510(k) clearance K972077 for EPI-STOP EPISTAXIS CATHETER, Substantially Equivalent on 1997-06-26. Applicant: Boston Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Boston Medical Products, Inc.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1997-06-03
Decision date: 1997-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, 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.