INTRAUTERINE HEMOSTASIS BALLOON STENT— 510(k) K863439

Name: FDA 510(k) clearance K863439
Creator: U.S. Food and Drug Administration
Published: 1987-06-02

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K863439 for INTRAUTERINE HEMOSTASIS BALLOON STENT, Substantially Equivalent on 1987-06-02. Applicant: Mentor Corp.. Device class: 2.

Clearance details

Applicant: Mentor Corp.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1986-09-05
Decision date: 1987-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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