CARBOMEDICS SUPRA-ANNULAR VALVE SIZER— 510(k) K952184

Name: FDA 510(k) clearance K952184
Creator: U.S. Food and Drug Administration
Published: 1995-11-29

Substantially Equivalent

Carbomedics, Inc.

FDA 510(k) clearance K952184 for CARBOMEDICS SUPRA-ANNULAR VALVE SIZER, Substantially Equivalent on 1995-11-29. Applicant: Carbomedics, Inc.. Device class: 1.

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code DTI
Device class: Class 1
Regulation: 21 CFR 870.3945
Advisory panel: Cardiovascular
Date received: 1995-05-09
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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