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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 K160166
Device Name X-MIND trium
Applicant
De Gotzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Applicant Contact Olivier Balouka
Correspondent
De Gotzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Correspondent Contact Olivier Balouka
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received01/27/2016
Decision Date 11/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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