DIGORA PCT— 510(k) K012170

Substantially Equivalent

Soredex Palodex Group OY

FDA 510(k) clearance K012170 for DIGORA PCT, Substantially Equivalent on 2001-08-10. 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: 2001-07-12
Decision date: 2001-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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