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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K163423
Device Name Orthopantomograph OP300
PaloDEx Group Oy
Nahkelantie 160
Tuusula,  FI FI-04300
Applicant Contact Eric Schwandt
PaloDEx Group Oy
Nahkelantie 160
Tuusula,  FI FI-04300
Correspondent Contact Eric Schwandt
Regulation Number892.1750
Classification Product Code
Date Received12/06/2016
Decision Date 08/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No