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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, Extraoral Source, Digital
510(k) Number K063837
Device Name SIGMA M
Applicant
Instrumentarium Dental, Palodex Group OY
Nahkelantie 160
Tuusula,  FI 04300
Applicant Contact JOUNI ONNELA
Correspondent
Instrumentarium Dental, Palodex Group OY
Nahkelantie 160
Tuusula,  FI 04300
Correspondent Contact JOUNI ONNELA
Regulation Number872.1800
Classification Product Code
MUH  
Date Received12/26/2006
Decision Date 07/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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