OP300— 510(k) K133544

Substantially Equivalent

Palodex Group OY

FDA 510(k) clearance K133544 for OP300, Substantially Equivalent on 2014-03-26. Applicant: Palodex Group OY.

Clearance details

Applicant: Palodex Group OY
Product code: Code OAS
Advisory panel: Radiology
Date received: 2013-11-18
Decision date: 2014-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Tuusula, FI

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