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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K033755
Device Name MINRAY
Applicant
Soredex Palodex Group OY
Elimaenkatu 22
Helsinki,  FI FIN 00510
Applicant Contact KAI LANER
Correspondent
Soredex Palodex Group OY
Elimaenkatu 22
Helsinki,  FI FIN 00510
Correspondent Contact KAI LANER
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/01/2003
Decision Date 04/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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