CRANEX TOME CEPH, OR CRANEX TOME— 510(k) K974877

Name: FDA 510(k) clearance K974877
Creator: U.S. Food and Drug Administration
Published: 1998-03-27

Substantially Equivalent

Orion Corporation Soredex

FDA 510(k) clearance K974877 for CRANEX TOME CEPH, OR CRANEX TOME, Substantially Equivalent on 1998-03-27. Applicant: Orion Corporation Soredex. Device class: 2.

Clearance details

Applicant: Orion Corporation Soredex
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 1997-12-29
Decision date: 1998-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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