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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 K122018
Device Name OP300
Original Applicant
PALODEX GROUP OY
nahkelantie 160
tuusula,  FI 04300
Original Contact matti tulikoura
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/10/2012
Decision Date 12/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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