HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY— 510(k) K875344

Name: FDA 510(k) clearance K875344
Creator: U.S. Food and Drug Administration
Published: 1988-03-18

Substantially Equivalent

Kulzer, Inc.

FDA 510(k) clearance K875344 for HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY, Substantially Equivalent on 1988-03-18. Applicant: Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Kulzer, Inc.
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1987-12-30
Decision date: 1988-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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