SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR— 510(k) K974648

Name: FDA 510(k) clearance K974648
Creator: U.S. Food and Drug Administration
Published: 1998-08-04

Substantially Equivalent

Sulzer Carbomedics, Inc.

FDA 510(k) clearance K974648 for SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR, Substantially Equivalent on 1998-08-04. Applicant: Sulzer Carbomedics, Inc.. Device class: 1.

Clearance details

Applicant: Sulzer Carbomedics, Inc.
Product code: Code MOP
Device class: Class 1
Regulation: 21 CFR 870.3935
Advisory panel: Cardiovascular
Date received: 1997-12-12
Decision date: 1998-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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