DIGORA PCT/DIGIPOD— 510(k) K070304

Substantially Equivalent

Soredex Palodex Group OY

FDA 510(k) clearance K070304 for DIGORA PCT/DIGIPOD, Substantially Equivalent on 2007-03-27. Applicant: Soredex Palodex Group OY. Device class: 2.

Clearance details

Applicant: Soredex Palodex Group OY
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2007-01-31
Decision date: 2007-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, FI

Download summary PDF View on FDA.gov ↗

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