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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
Applicant
PALODEX GROUP OY
NAHKELANTIE 160
TUUSULA,  FI 04300
Applicant Contact MATTI TULIKOURA
Correspondent
PALODEX GROUP OY
NAHKELANTIE 160
TUUSULA,  FI 04300
Correspondent 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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