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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K140660
Device Name MOBIUS3D
Applicant
Mobius Medical Systems, LP
5012 Tamarisk St.
Bellaire,  TX  77401
Applicant Contact STAN ESHELMAN
Correspondent
Mobius Medical Systems, LP
5012 Tamarisk St.
Bellaire,  TX  77401
Correspondent Contact STAN ESHELMAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/14/2014
Decision Date 06/24/2014
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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