OP300— 510(k) K122018

Substantially Equivalent

Palodex Group OY

FDA 510(k) clearance K122018 for OP300, Substantially Equivalent on 2012-12-10. Applicant: Palodex Group OY.

Clearance details

Applicant: Palodex Group OY
Product code: Code OAS
Advisory panel: Radiology
Date received: 2012-07-10
Decision date: 2012-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Tuusula, FI

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