CRANEX BASEX D OR CRANEX EXCEL D— 510(k) K040382

Name: FDA 510(k) clearance K040382
Creator: U.S. Food and Drug Administration
Published: 2004-07-13

Substantially Equivalent

Soredex Palodex Group OY

FDA 510(k) clearance K040382 for CRANEX BASEX D OR CRANEX EXCEL D, Substantially Equivalent on 2004-07-13. Applicant: Soredex Palodex Group OY. Device class: 2.

Clearance details

Applicant: Soredex Palodex Group OY
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2004-02-17
Decision date: 2004-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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