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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K121418
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
JAK  
Date Received05/11/2012
Decision Date 02/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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