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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, X-Ray System
510(k) Number K153583
Device Name BioVision Plus
Applicant
Faxitron Bioptics, LLC
3440 E. Britannia Dr.
Suite 150
Tucson,  AZ  85743
Applicant Contact CARLOS REYES
Correspondent
Faxitron Bioptics, LLC
3440 E. Britannia Dr.
Suite 150
Tucson,  AZ  85743
Correspondent Contact CARLOS REYES
Regulation Number892.1680
Classification Product Code
MWP  
Date Received12/15/2015
Decision Date 04/01/2016
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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