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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, Tomography, Computed
510(k) Number K032243
Device Name MINICAT DENTOCAT
Applicant
Xoran Technologies, Inc.
309 N. First St.
Ann Arbor,  MI  48103
Applicant Contact PREDRAG SUKOVIC
Correspondent
Xoran Technologies, Inc.
309 N. First St.
Ann Arbor,  MI  48103
Correspondent Contact PREDRAG SUKOVIC
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/22/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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