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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 K092591
Device Name ORTHOPANTOMOGRAPH OP30
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 Received08/24/2009
Decision Date 11/20/2009
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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