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510(k) K220300

Device
OTOPLAN
Applicant
Cascination AG
510(k) number
K220300
Product code
QQE  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-24
Date received
2022-02-02
Regulation
892.2050
Classification name
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Medical specialty
Radiology
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jean-Francois Clemence
Address
Steigerhubelstrasse 3 Bern CH 3008 3008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QQE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242120OTOPLANCascination AG2025-04-11
K203486OtoplanCascination AG2021-08-20

Legacy Summary#

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FDA Review#

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