COMPOLUTE APLICAP— 510(k) K974458

Name: FDA 510(k) clearance K974458
Creator: U.S. Food and Drug Administration
Published: 1998-02-02

Substantially Equivalent

Espe Dental-Medizin GmbH & Co.Kg.

FDA 510(k) clearance K974458 for COMPOLUTE APLICAP, Substantially Equivalent on 1998-02-02. Applicant: Espe Dental-Medizin GmbH & Co.Kg.. Device class: 2.

Clearance details

Applicant: Espe Dental-Medizin GmbH & Co.Kg.
Product code: Product code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1997-11-25
Decision date: 1998-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.