SERENOCEM, MODEL BC 010— 510(k) K003567

Name: FDA 510(k) clearance K003567
Creator: U.S. Food and Drug Administration
Published: 2001-02-12

Substantially Equivalent

Corinthian Medical , Ltd.

FDA 510(k) clearance K003567 for SERENOCEM, MODEL BC 010, Substantially Equivalent on 2001-02-12. Applicant: Corinthian Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Corinthian Medical , Ltd.
Product code: Code NEA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2000-11-20
Decision date: 2001-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

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