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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 K180947
Device Name Orthopantomograph OP 3D
Applicant
PaloDEx Group Oy
Nahkelantie 160
Tuusula,  FI 04300
Applicant Contact Terho Turkumaki
Correspondent
PaloDEx Group Oy
Nahkelantie 160
Tuusula,  FI 04300
Correspondent Contact Terho Turkumaki
Regulation Number892.1750
Classification Product Code
OAS  
Date Received04/11/2018
Decision Date 06/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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