REMANIUM:GM 700, GM 380, GM 800, GFH— 510(k) K952867

Name: FDA 510(k) clearance K952867
Creator: U.S. Food and Drug Administration
Published: 1995-07-27

Substantially Equivalent

Dentauraum, Inc.

FDA 510(k) clearance K952867 for REMANIUM:GM 700, GM 380, GM 800, GFH, Substantially Equivalent on 1995-07-27. Applicant: Dentauraum, Inc.. Device class: 2.

Clearance details

Applicant: Dentauraum, Inc.
Product code: Code EJH
Device class: Class 2
Regulation: 21 CFR 872.3710
Advisory panel: Dental
Date received: 1995-06-22
Decision date: 1995-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

Download summary PDF View on FDA.gov ↗

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