CARBOMEDICS EXENDED MITRAL ROTATOR— 510(k) K951368

Name: FDA 510(k) clearance K951368
Creator: U.S. Food and Drug Administration
Published: 1995-06-20

Substantially Equivalent

Carbomedics, Inc.

FDA 510(k) clearance K951368 for CARBOMEDICS EXENDED MITRAL ROTATOR, Substantially Equivalent on 1995-06-20. Applicant: Carbomedics, Inc.. Device class: 1.

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code MOP
Device class: Class 1
Regulation: 21 CFR 870.3935
Advisory panel: Cardiovascular
Date received: 1995-03-27
Decision date: 1995-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, 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.