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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 K180918
Device Name Planmed Verity
Applicant
Planmed OY
Sorvaajankatu 7
Helsinki,  FI 00880
Applicant Contact Lars Moring
Correspondent
Planmed OY
Sorvaajankatu 7
Helsinki,  FI 00880
Correspondent Contact Lars Moring
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
JAK  
Date Received04/09/2018
Decision Date 11/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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