AUSTENAL CONDENSING INSTRUMENT— 510(k) K865025

Name: FDA 510(k) clearance K865025
Creator: U.S. Food and Drug Administration
Published: 1987-02-19

Substantially Equivalent

Austenal Dental, Inc.

FDA 510(k) clearance K865025 for AUSTENAL CONDENSING INSTRUMENT, Substantially Equivalent on 1987-02-19. Applicant: Austenal Dental, Inc.. Device class: 1.

Clearance details

Applicant: Austenal Dental, Inc.
Product code: Code EKG
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1986-12-23
Decision date: 1987-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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