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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K161444
Device Name DBSWIN and VistaEasy Imaging Software
Applicant
Duerr Dental AG
Hoepfigheimer St. 17
Bietigheim-Bissingen,  DE D-74321
Applicant Contact Oliver Lange
Correspondent
Air Techniques, Inc.
1295 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact Suzanne Lucas
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/25/2016
Decision Date 06/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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